National Institute of

Standards and Technology

Technology Administration

U.S. Department of Commerce

7028

July 2003

NISTIR

Type Evaluation Laboratory

Quality Manual Template

Developed for U.S. Type Evaluation

Laboratories

WEIGHTS

AND MEASURES DIVISION
Quality 

Manual 

Template

 

 Type Evaluation Laboratory 

 Quality Manual Template 

 Developed for U.S. Type Evaluation Laboratories 

 

 G. Diane Lee July 2003 

 NIST Weights and Measures Division 

 Henry Oppermann, Division Chief 

 Gaithersburg, MD 20899 

 

U.S. DEPARTMENT OF COMMERCE 

Donald L. Evans, Secretary 

TECHNOLOGY ADMINISTRATION 

Phillip J. Bond, Under Secretary of Commerce For Technology

NATIONAL INSTITUTE OF STANDARDS 

AND TECHNOLOGY 

Arden L. Bement, Jr., Director

NISTIR 7028
Preface 

The National Institute of Standards and Technology (NIST) Weights and Measures Division 

(WMD) works with State weights and measures (W&M) programs and other federal agencies to 

promote uniformity in the U.S. commercial W&M system. Some State W&M programs and 

federal agencies maintain and operate type evaluation laboratories. These laboratories perform

evaluations of commercial weighing and measuring devices to ensure their conformance to 

national (National Conference on Weights and Measures, NCWM Publication 14 test 

procedures), and international (International Organization of Legal Metrology, OIML 

recommendations) standards. 

In accordance with ISO/IEC 17025 “General Requirements for the Competence of Testing and 

Calibration Laboratories, ” 1999, U.S. type evaluation laboratories must establish, implement, 

maintain and document their laboratory quality system. 

As part of its technical support to the U.S. commercial W&M system, NIST WMD created this 

quality manual template to assist type evaluation laboratories in documenting their quality 

systems. As such, this quality manual template is specifically designed for type evaluation 

testing laboratories. The quality manual template is based on ISO/IEC 17025 requirements. 

Although this manual is not numerically formatted identical to the ISO/IEC 17025 standard, the 

requirements of the standard are addressed in the quality manual. Each Section of the quality 

manual is cross-referenced to the ISO/IEC 17025 requirements so that auditors and others can 

locate where the requirements are addressed in the quality manual. 

The U.S. type evaluation laboratories are encouraged to use the template to document their 

laboratory quality system. Other testing laboratories may also use this template to assist them in 

documenting their quality system. 

i
Acknowledgments 

Special thanks go to the following individuals and groups for their technical contributions, 

reviews and input in the preparation of this quality manual template. 

The NIST Office of Weights and Measures staff 

Tina Butcher 

Georgia Harris 

Steve Cook 

Lynn Sebring 

Doug Faison, NIST National Voluntary Laboratory Accreditation Program

Dr. George Mattingly, NIST Process Measurements Division 

Andrea Buie, Maryland Department of Agriculture, Weights and Measures Section 

U.S. type evaluation laboratories 

ii
Introduction 

The type evaluation quality manual template has 20 Sections followed by Appendices A through 

R. The appendices are referenced throughout the template. The table of appendices (page viii) 

cross-references each appendix to its section reference in the template. The following table 

(page ix) cross-references both ISO/IEC 17025 and NIST Handbook 150 “NVLAP Procedures 

and General Requirements,” 2001, to the quality manual sections of the template. 

Using the tables of cross-references, the laboratory should review and edit the sections so that 

they collectively represent the quality system of the laboratory in accordance with the ISO/IEC 

17025 standard. In a situation where the laboratory policies or procedures differ from the 

ISO/IEC 17025 standard, the laboratory policies or procedures must be changed to ensure 

conformance to the standard. This template includes descriptions of how a laboratory may meet 

the requirements of ISO/IEC 17025, which may or may not be how your laboratory chooses to 

meet the requirements. As such, the template must be tailored to describe how your laboratory 

quality system meets the requirements of ISO/IEC 17025. 

 

iii
________________ Type Evaluation Laboratory 

12345 Some St. 

Special City, ST 54321 

Adoption: 

QUALITY MANUAL 

(Based on ISO/IEC 17025) 

Issued under the authority of 

the director of the State Bureau of Standards pursuant to Statute CXY. 

Adopted by: 

Title/Position: 

Signature: 

Date: 

 

Document Control: 

Issue Date 

Issued to 

Controlled Y N 

Copy No. 

No. of Pages 

Controlled issues of the Quality Manual may not be copied.

This quality manual is controlled in its entirety as updates or revisions are made. 

 Revisions to the appendices are controlled and each distributed separately as updates and revisions 

are made. 

 Revisions to the appendices are controlled and maintained in the laboratory. Updates or revisions to 

appendices must be requested. 

iv
REVISIONS TO THE QUALITY MANUAL 

DATE SECTION NO. PAGE NO. PARAGRAPH NO. COMMENTS APPROVAL: 

NAME SIGNATURE 

v
REVISIONS TO THE APPENDICES 

DATE APPENDIX APPROVAL: 

NO. 

PAGE NO. PARAGRAPH NO. COMMENTS 

NAME SIGNATURE 

vi
QUALITY MANUAL 

Table of Contents 

Section Title Date and 

Revision 

Page 

1 Scope and Parameters 

July 1, 2003 

Rev. 1 1 

2 References and Definitions 

July 1, 2003 

Rev. 1 2-3 

3 Quality Policy 

July 1, 2003 

Rev. 1 4-5 

4 

Service to the Client and Review of Contract, Tender and Work 

Request 

July 1, 2003 

Rev. 1 6-7 

5 Organization and Management 

July 1, 2003 

Rev. 1 8-11 

6 

Quality System, Document Control, Internal Audits and 

Management Reviews 

July 1 2003 

Rev. 1 12-18 

7 Personnel 

July 1, 2003 

Rev. 1 19-20 

8 Laboratory Facilities and Environment 

July 1, 2003 

Rev. 1 21-22 

9 Standards, Equipment and Associated Apparatus 

July 1, 2003 

Rev. 1 23-26 

10 Measurement Traceability and Calibration 

July 1, 2003 

Rev. 1 27-29 

11 Type Evaluation Test Methods and Procedures 

July 1, 2003 

Rev. 1 30-32 

12 Handling and Storage of Test Items 

July 1, 2003 

Rev. 1 33-34 

13 Records 

July 1, 2003 

Rev. 1 35-38 

14 Type Evaluation Test Reports (Certificates of Conformance) 

July 1, 2003 

Rev. 1 39-42 

15 Subcontracting 

July 1, 2003 

Rev. 1 43 

16 Outside Support Services and Supplies 

July 1, 2003 

Rev. 1 44 

17 Preventive Action / Complaints and Corrective Action 

July 1, 2003 

Rev. 1 45-46 

18 Site Security 

July 1, 2003 

Rev. 1 47-48 

19 Safety 

July 1, 2003 

Rev. 1 49 

20 Sampling 

July 1, 2003 

Rev. 1 50 

vii
Table of Appendices 

Item

Section 

Reference Title Page

A 2 Definitions 51-52 

B 5, 6 Organization Charts 53-54 

C 1, 3 Measurement Parameters 55-56 

D 6, 8 Diagram of Laboratory Facilities 57 

E 6, 8 Environmental Conditions 58 

F 6, 9 Equipment and Materials 59-60 

G 6, 9 Standards and Reference Materials 61 

H 

3, 4, 5, 6, 7, 8, 9, 

10, 11, 12, 13, 

14, 16, 17, 20 

Procedures List (Measurement Procedures; Administrative 

Procedures) 62-65 

I 10 Assessment of Uncertainties 66 

J 6, 10 Control Charts List 67 

K 6, 10 Proficiency Tests 68 

L 6, 7 Personnel Training and Competency 69 

M 5, 6, 7 Job Descriptions and/or Duty Statements 70-72 

N 6, 19 Document Control 73-77 

O 

6, 8, 9, 11, 12, 

13, 17 

Forms (Blank) 

- Personnel Training and Competency 

- Calibration and Maintenance Log (Standards and Equipment) 

- Software Program Verification 

- Equipment Assessment 

- Proficiency Test Results 

- Audit Log 

- Work Log 

- Complaints/Corrective Action 

- Environmental Conditions/Deviations Log 

- Subcontractors and outside Suppliers Verification Log 78-88 

P 12, 14 Weighing Device Evaluation Process Flowcharts 89-98 

Q 6 Documentation Outline 99 

R 9, 10 Traceability Flowchart 100 

viii
Quality Manual Cross-Referenced to 

 ISO/IEC 17025 and NIST HB 150 

QM 

Section Title 

ISO/IEC 17025 

NIST HB 150 

1 Scope and Parameters 1, 4.2.1 

2 References and Definitions 2, 3 

3 Quality Policy 4.2.1, 4.2.2, 4.2.3 

4 

Service to the Client and Review of Contracts, Tenders and Work 

Request 4.4, 4.7 

5 Organization and Management 4.1, 4.2.4 

6 

Quality System, Document Control, Internal Audits and 

Management Reviews 4.2.1, 4.2.3, 4.13, 4.14, 4.3 

7 Personnel 5.1, 5.2 

8 Laboratory Facilities and Environment 5.3 

9 Standards, Equipment and Associated Apparatus 5.1, 5.5 

10 Measurement Traceability and Calibration 5.4.6, 5.6, 5.9(b) 

11 Type Evaluation Test Methods and Procedures 4.9, 5.1, 5.4, 5.9 

12 Handling and Storage of Test Items 5.8 

13 Records 4.12

14 Type Evaluation Test Reports (Certificates of Conformance) 4.9, 5.10 

15 Subcontracting 4.5

16 Outside Support Services and Supplies 4.6 

17 Preventive Action / Complaints and Corrective Action 4.8, 4.10, 4.11 

18 Site Security 5.3, 5.8 

19 Safety ----- 

20 Sampling 5.7

ix
QM Section 2 

Page 1 of 2 References and Definitions 

2.0 References and Definitions

All critical references cited in this quality manual are maintained on file in the laboratory 

and are accessible to all laboratory staff and management. 

2.1 Critical References 

2.1.1 ISO/IEC 17025, General Requirements for the Competence of Testing and 

 Calibration Laboratories, 1999 

2.1.2 National Conference on Weights and Measures, Publication 14 NTEP 

Administrative Procedures, Technical Policy, Checklists and Test Procedures, 

2003. 

2.1.3 NIST Handbook 44, Specifications, Tolerances, and other Technical 

Requirements for Weighing and Measuring Devices, 2003, Tina Butcher, Terry 

Grimes, Juana Williams, Richard Suiter 

2.1.4 NIST Technical Note 1297, Guidelines for Evaluating and Expressing the 

Uncertainty of NIST Measurement Results, 1994, Barry N. Taylor and Chris E. 

Kuyatt 

2.1.5 National Conference of Standards Laboratories (NCSL), Recommended 

Practice (RP) No. 7, Laboratory Design, 1993. 

2.1.6 Applicable State laws and department policies and guidelines [NOTE: include 

State statutes, which denote the legal status of the type evaluation laboratory]. 

2.2 Additional References 

2.2.1 NIST HB 130, Uniform Laws and Regulations, 2002, Thomas Coleman and 

Terry L. Grimes 

[NOTE: This quality manual was written following the requirements of ISO/IEC 17025, 1999 

and modified to promote a specific quality assurance program for a type evaluation laboratory.]

_____________________________________________________________________________

NISTIR 7028 July 2003 2 
QM Section 2 

Page 2 of 2 

References and Definitions 

2.3 Definitions 

Definitions are contained in Appendix A. 

_____________________________________________________________________________

NISTIR 7028 July 2003 3 
QM Section 3 

Page 1 of 2 Quality Policy 

3.0 Quality Policy

3.1 Policy 

3.1.1 This quality policy is issued under the authority of the chief executive [NOTE: 

enter title used]. 

3.1.2 The laboratory conducts all device type evaluations under laboratory and field 

conditions that are suitable for the test being conducted and by using techniques 

that are conducive to a high degree of reliability and follows recognized type 

evaluation procedures as noted in Appendix H. It is our policy to provide the 

highest reasonable quality type evaluation services attainable to clients through 

continuous improvement of the quality system. Quality in our services is a 

constant effort and focus. 

 

3.1.3 The objective of this quality manual is to establish a documented quality system

that provides for continuous improvement of that quality system to ensure 

reliable and accurate test results. 

3.1.4 All laboratory personnel who perform type evaluation testing are familiar with 

the quality documentation, which is implemented in their work, policies and 

procedures. The laboratory quality manager provides copies of the quality 

documentation to the laboratory staff and/or informs the staff of its location. 

Laboratory staff review the documentation as part of their on-the-job training, 

which is recorded in their training records. The quality system documentation 

includes: 

 

3.1.4.1 Laboratory quality manual; 

3.1.4.2 Type evaluation test procedures: NCWM Publication 14 “NTEP 

 Administrative Procedures, Technical Policy, Checklist, and Test 

 Procedures referenced in Section 2 (see Appendix H), and OIML 

 recommendations; 

3.1.4.3 Administrative procedures as required by ISO/IEC 17025 (see 

 Appendix H); 

3.1.4.4 Work instructions; 

3.1.4.5 Records, forms, and reports (see Section 13, Records)

______________________________________________________________________________ 

NISTIR 7028 4 July 2003 
QM Section 3 

Page 2 of 2 Quality Policy 

3.1.4.6 Equipment instruction manuals (maintained in the laboratory). 

3.1.5 The supporting documents and procedures are referenced in this quality manual, 

but are maintained separately from the quality manual. 

3.2 Tests 

3.2.1 The laboratory evaluates the devices listed in Appendix C in accordance with 

the procedures, practices, and conditions (hereafter referred to as "procedures") 

of the National Conference on Weights and Measures Publication 14 (see 

references, Section 2). The techniques used for specific tests are within the 

applicable State administrative guidelines and associated safety and costeffective considerations. 

3.3 Authorization and/or Accreditation 

[NOTE: Edit this section as it applies to your laboratory.] 

3.3.1 The type evaluation laboratory is authorized by __________________________ 

to demonstrate conformance to ISO/IEC 17025. 

and/or 

3.3.2 The type evaluation laboratory is accredited by the National Voluntary 

Laboratory Accreditation Program (NVLAP) to demonstrate conformance to 

ISO/IEC 17025 (through NIST HB 150). 

A current authorization and/or accreditation certificate is prominently displayed 

and maintained on the wall in the laboratory. The laboratory does not conduct 

type evaluation testing or issue reports for nonauthorized areas of evaluation. 

______________________________________________________________________________ 

NISTIR 7028 5 July 2003 
QM Section 4 

Page 1 of 2 

Service to the Client and Review of Contract, Tenders, 

and Work Request 

4.0 Service to the Client and Review of Contract, Tenders, and Work Request 

4.1 Service to the Client 

4.1.1 As necessary, the laboratory works with the client to clarify test requests, device 

operation and test results. The client is provided controlled access to the 

laboratory to observe type evaluations of the device. To ensure confidentiality, 

information and devices of other clients are not visible during a client visit to the 

laboratory. The laboratory communicates with the client at any time prior to, 

during and after the type evaluation as needed to address any questions, changes 

and test results. The laboratory provides the client with a summary and 

conclusion of the test results. The laboratory may receive feedback from the 

client that might improve the laboratory quality system. As appropriate client 

feedback will be reviewed by the quality manager and used to improve the quality 

system (see Appendix H, AP No. 6). 

4.2 Review of Contract, Tenders, and Work Request (Application) 

4.2.1 Contracts, tenders, and work requests received by the laboratory are in the form

of type evaluation applications. Applications are received by the type evaluation 

manager as a request for testing. Typically the type evaluation manager reviews 

the application, and in many cases the review involves an evaluation of the 

laboratory workload and other essential factors before the device is assigned to 

the laboratory. Procedures are maintained for the review of type evaluation 

applications that lead to an agreement for testing (see Appendix H, AP No. 21). 

The procedures ensure that: 

4.2.1.1 The requirements and test used are defined and understood 

4.2.1.2 The laboratory is capable of meeting the requirements and has the 

 necessary resources; and 

4.2.1.3 The work does not begin until there is agreement between the laboratory 

and the client.

______________________________________________________________________________ 

NISTIR 7028 6 July 2003 
QM Section 4 

Page 2 of 2 

Service to the Client and Review of Contract, Tenders, 

and Work Request 

4.2.2 Records of the application review and client discussions are maintained in the 

laboratory. (See Section 13 Records.) 

4.2.3 Application reviews include any work that is subcontracted by the laboratory. 

The client is informed of any deviations from the application; if the 

application is amended after the work starts, the same review process is 

followed for an amendment to the application 

4.2.4 The laboratory cooperates with the client to ensure that the application is 

understood. The laboratory calls the client upon receipt of the application 

and reviews the application with the client. Prior to testing the laboratory and 

the client discuss any abnormalities. 

______________________________________________________________________________ 

NISTIR 7028 7 July 2003 
QM Section 5 

Page 1 of 4 Organization and Management 

5.0 Organization and Management

5.1 Legal Status 

5.1.1 The type evaluation laboratory is maintained under State statute XYZ [NOTE: 

enter State statute title, number, and/or article number]. 

OR 

5.1.1 The type evaluation laboratory is maintained under NIST HB 130, Uniform

Laws and Regulations, Uniform Regulation for National Type Evaluation, 

which is adopted by State statute XYZ. 

5.2 Organization 

5.2.1 The type evaluation laboratory is part of the State or Federal Government [NOTE: 

enter State or Federal agency and department of the State or Federal agency that 

the laboratory is a part of]. Authority, interrelation, and responsibilities of all 

laboratory personnel are on file in the form of job descriptions contained in 

Appendix M and organizational charts provided in Appendix B. The laboratory 

manager designates staff responsibilities of quality and technical managers and 

deputies. The quality and technical managers are designated based on knowledge 

of the quality system and technical activities of the laboratory. (See laboratory 

organization chart, Appendix B.) In the event that either the quality or technical 

manager is absent for an extended period, his/her duties are assigned to deputies. 

5.2.2 Testing activities are conducted such that they meet the requirements of ISO/IEC 

17025 and this quality manual, and satisfy the needs of the client and the 

regulatory authorities and/or organizations providing authorization and/or 

accreditation. 

5.2.3 The laboratory performs some evaluations of weighing and measuring devices at 

sites that are outside the permanent laboratory facilities. These sites may be 

located at a device owner’s facility or other site, either within a building or 

outdoors. Site evaluations are conducted in accordance with the laboratory 

management system. 

5.2.4 The responsibilities of key personnel in the organization who perform other 

_____________________________________________________________________ 

NISTIR 7028 8 July 2003 
QM Section 5 

Page 2 of 4 Organization and Management 

activities and who have an involvement or influence on the testing activities of 

the laboratory are defined in order to identify potential conflicts of interest. A list 

of key personnel performing other activities is maintained in the laboratory. The 

list includes their current position, in the type evaluation laboratory, other 

activities conducted, and a statement as to whether or not any conflict exists. (See 

Quality Manual Section 13 Records, “List of Key Personnel Performing other 

Activities.”) Laboratory personnel do not participate in activities that might 

adversely affect confidence in the type evaluation (see Appendix H, AP No. 24). 

5.3 Responsibility 

The managerial and technical personnel of the laboratory are equipped with the authority 

and resources to perform their duties. The laboratory personnel responsibilities are 

defined below. 

[NOTE: The following is an example of laboratory personnel responsibilities. The type 

evaluation laboratories must edit this section so that the titles and responsibilities of your 

laboratory personnel are reflected in this section.] 

5.3.1 Director 

5.3.1.1 The Director is responsible for the overall compliance of the 

laboratory to this quality manual and has direct responsibility for the 

type evaluation laboratory, which includes final approval of all 

changes made to the quality manual. The Director participates in 

management reviews of the quality system

 

5.3.2 Management (Laboratory Manager, however named) 

5.3.2.1 The management of the laboratory: 

a. implements and enforces the applicable good laboratory 

practices described in reference documents; 

b. provides resources, adjusts workloads, and provides training 

opportunities for laboratory staff to facilitate completion of 

assigned tasks in a safe work environment consistent with test 

requirements and personnel capabilities; 

c. assigns deputies for both the technical and quality managers in

_____________________________________________________________________ 

NISTIR 7028 9 July 2003 
QM Section 5 

Page 3 of 4 Organization and Management 

the case of an absence; 

d. participates in management reviews of the quality system; and 

e. supervises the activities of the laboratory 

5.3.3 Technical Manager or Deputy [NOTE: The deputy may or may not have the 

same duties as the technical manager.]

5.3.3.1 The technical manager: 

a. is a type evaluation laboratory person who has completed the 

appropriate level of type evaluation training as specified in the 

laboratory training procedures in the areas for which the 

laboratory is authorized; 

b. is responsible for the overall administrative and technical 

operations of the laboratory; 

c. specifies and/or approves all methodologies used; 

d. implements good laboratory practices by providing instruction 

and training as needed, develops work plans and procedures, and 

requires that these be followed in all day-to-day operations; 

e. verifies personnel training; 

f. assigns only competent personnel to complete tests; 

g. attests, by signature, to the validity of all laboratory tests 

performed and reports (a list of approved signatories is 

maintained in the laboratory (see Quality Manual Section 13 

Records); 

h. ensures continued authorization of the laboratory; 

i. where necessary, identifies, develops, and implements 

improvement of the laboratory measurement capability to meet 

the requirements of ISO/IEC17025, department programs, and 

laboratory clients; and 

j. participates in management reviews of the quality system. 

5.3.4 Quality Manager or Deputy [NOTE: The deputy may or may not have the same

duties as the quality manager.]

5.3.4.1 The quality manager: 

a. is a type evaluation laboratory person who has completed the 

required level of training as specified in the laboratory training

_____________________________________________________________________ 

NISTIR 7028 10 July 2003 
QM Section 5 

Page 4 of 4 Organization and Management 

procedures in the areas for which the laboratory is authorized; 

b. coordinates internal audits of the laboratory in accordance with 

Section 6 of this quality manual; 

c. participates in available and relevant proficiency tests, round 

robins, and/or interlaboratory collaborative studies; 

d. maintains the quality manual; 

e. has direct access to management and to the technical manager; 

f. identifies departures from the quality system or from procedures, 

 and initiate actions to prevent or minimize such departures, 

g. coordinates and participates in management reviews of the 

quality system; and 

h. supervises the quality activities of the laboratory. 

[NOTE: Type evaluation laboratories may be limited in staff. One person or a part-time person 

may operate these laboratories. In these cases, one person has the responsibilities of both 

technical and quality manager. Special care and precaution must be taken and documented to 

ensure that limited laboratory staff does not adversely affect the quality system and type 

evaluations.] 

 

5.4 Independence 

5.4.1 Management ensures that the laboratory is independent from any pressures – 

commercial, financial, or others, which adversely affect the quality of test and 

resulting reports. State policy provides guidelines to ensure laboratory 

independence. [NOTE: As appropriate the laboratory should reference the State 

policy.] 

5.5 Confidentiality 

5.5.1 The laboratory maintains the confidentiality and proprietary rights of all 

information, including the type of work performed and the results of tests to the 

extent allowable by State law and in accordance with the administrative 

procedures. [NOTE: The laboratory should include the specific State law in this 

statement and document the law in Section 2 of the quality manual.] All 

laboratory personnel and staff are informed of this policy. (See Appendix H, 

AP No. 1, Procedures for Client Confidentiality and Proprietary Rights.)

_____________________________________________________________________ 

NISTIR 7028 11 July 2003 
QM Section 6 

Page 1 of 7 

Quality System, Document Control, Internal Audits and 

Management Reviews 

6.0 Quality System, Document Control, Internal Audits and Management Reviews 

6.1 The type evaluation laboratory has established and maintains a quality system that 

supports the tests conducted by the laboratory. The quality system is described in 

this quality manual, the appendices, and applicable sections of the references 

named herein. These documents are readily available to all laboratory staff and 

serve as the basis for evaluating the integrity of the measurements and associated 

reports. The laboratory conducts internal audits of the laboratory quality system

on behalf of management to ensure that the laboratory's policies and procedures 

as set forth in this quality manual are being followed. Management periodically 

reviews the quality system, including review of internal audit results (see 

Appendix H, AP No. 7, Procedures for Internal Audits and Management Review). 

6.2 Quality System

6.2.1 The basic elements of the quality system include: 

6.2.1.1 the quality manual; 

6.2.1.2 NCWM Publication 14 test procedures (see 

Appendix H and also Section 11); 

6.2.1.3 work instructions (maintained in the laboratory); 

6.2.1.4 records, forms, reports (see section 13, Appendix O 

and Section 14); and 

6.2.1.5 equipment instruction manuals (maintained in the 

laboratory) 

6.2.2 To ensure proper operation of the quality system, there are: 

6.2.2.1 Qualified personnel for each measurement (see Section 7, Personnel, 

Appendices L, Personnel Training & Competency and M, Job 

Descriptions and Duty Statements); 

6.2.2.2 Management and senior personnel reviews and supervision (see

______________________________________________________________________________ 

NISTIR 7028 12 July 2003 
QM Section 6 

Page 2 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

Section 5, Organization and Management, and Appendix B, 

Organization Chart); 

6.2.2.3 Appropriately maintained and calibrated working standards, 

equipment, and associated apparatus (see Section 9, Standards, 

Equipment and Associated Apparatus, Appendices G, Standards and 

Reference Materials and F, Equipment and Materials); 

6.2.2.4 Environmentally-controlled facilities, where appropriate, and/or 

proper accounting of relevant environmental factors (see Section 8, 

“Laboratory Facilities and Environment;” Appendices D, “Diagram

of Facilities” and E, “Environmental Conditions”); and 

6.2.2.5 Appropriate sampling procedures, where necessary (see Section 20). 

6.2.3 All elements of the quality system are considered when developing test methods 

and procedures, training and qualification of personnel and in the selection and 

calibration of equipment. 

6.3 Quality System Documentation 

6.3.1 An outline of the laboratory quality system documentation is in Appendix Q, 

Documentation Outline. 

6.3.2 Internal Document Control 

6.3.2.1 General 

6.3.2.1.1 Appendix N provides a detailed list of controlled 

documents with revision dates, retention periods, and 

locations. The procedures for document control include: 

a. information on document control numbers, 

b. designation of responsibility, 

c. assurance that authorized editions of appropriate 

documents are available at all locations that are 

essential to the proper functioning of the laboratory, 

d. periodic review and, as necessary, revision of the 

documents to ensure suitability and compliance with 

______________________________________________________________________________ 

NISTIR 7028 13 July 2003 
QM Section 6 

Page 3 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

e. applicable requirements, 

f. removal of invalid or obsolete documents, 

g. access and changes to hard and electronic document, 

and 

h. marking obsolete documents used for legal purposes. 

(See procedures list in Appendix H, AP No. 3, 

Document Control.) Section 13 Records lists the 

records maintained by the laboratory, the location of the 

records, and the retention time. Handwritten 

documents are clearly marked, initialed, and dated. 

6.3.2.1.2 All documents are reviewed and approved for use by 

authorized personnel prior to issuing the document to 

personnel in the laboratory. A control document 

distribution list is maintained in the laboratory, including 

the current revision status and distribution of the document. 

(See Appendix H, AP No. 3) 

6.3.2.1.3 Document changes are reviewed and approved following 

the same procedures for the original review process (see 

Appendix H, AP No. 3). The altered and/or new text is 

identified in the document. Handwritten changes to hard 

copy documents are clearly marked, initialed and dated by 

laboratory staff authorized to make changes to the 

documents. Some laboratory documents are maintained on 

the computer and changes are made electronically. These 

documents require a password to access the file or are readonly files and must be saved with a different file name

when changes are made. Changes in electronic documents 

are tracked by the word processing system and are accepted 

by authorized laboratory staff. Procedures and authorities 

are defined in Appendix H, AP No. 3, for handwritten and 

electronic changes. 

6.3.3 Authority 

6.3.3.1 Persons authorized to modify or update laboratory documents are 

included on the control document distribution list that is maintained 

______________________________________________________________________________ 

NISTIR 7028 14 July 2003 
QM Section 6 

Page 4 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

in the laboratory. The quality manager has the designated authority 

to modify or update the quality manual. The quality manual is 

annually reviewed and updated as needed by the end of September. 

The laboratory director is responsible for final approval of all 

changes made to the quality manual, and the revised document takes 

effect when signed and dated by the laboratory director. 

6.3.3.2 This quality manual (along with associated appendices and 

references) is available to all laboratory staff and management. 

Management is responsible for providing the documented quality 

system to staff and ensuring that all staff familiarize themselves and 

comply with the policies and procedures established in the manual 

and associated documentation. The quality manager notifies staff of 

the most current and approved version of the quality manual through 

memorandums or e-mails. 

6.3.4 Controlled Copies of the Quality Manual 

6.3.4.1 Controlled copies of this quality manual are issued to the director, 

program manager, type evaluation manager, and authorization or 

accreditation bodies, and are made available to all laboratory 

personnel. All controlled copies are marked as controlled and are 

numbered and updated by the quality manager whenever changes are 

made. Recipients of controlled copies are issued the revised quality 

manual. It is the responsibility of the quality manager to ensure that 

the most current quality manual is issued and followed by all 

laboratory and administrative staff. A list of the names, control 

numbers, and 

location of all controlled copies is maintained in the laboratory files. 

6.3.5 Uncontrolled Copies of the Quality Manual 

6.3.5.1 Uncontrolled copies of the quality manual are marked 

“uncontrolled”, issued upon request, and are not updated. 

6.4 Internal Audits and Management Reviews 

6.4.1 Internal Audits 

______________________________________________________________________________ 

NISTIR 7028 15 July 2003 
QM Section 6 

Page 5 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

6.4.1.1 The internal audit program addresses all elements of the quality 

system, including testing. A review of the quality system in 

accordance with ISO/IEC 17025 is conducted and a checklist 

is completed. Internal audit reports are maintained in the 

laboratory. The internal audits include an audit of the 

laboratory: 

a. Equipment 

b. Standards 

c. Staff (training needs) 

d. Facilities 

e. Quality documentation 

f. Management action items

g. Test results 

h. Statistical control data 

The laboratory quality manager annually plans the internal 

audit to review the laboratory's quality system and testing 

activities to ensure its continuing suitability and effectiveness 

and to introduce necessary changes or improvements. 

Internal audits are conducted in August to verify that 

operations continue to comply with the quality system. 

Auditors are trained in auditing techniques, have technical 

insight concerning the laboratory's functions, and (wherever 

possible) are independent of the activity to be audited. The 

laboratory manager investigates any deficiencies found 

during the internal audit to determine appropriate actions. If 

necessary, the laboratory manager will notify any clients 

whose tests were affected by the deficiency. (See Section 13 

Records and Appendix H, AP No. 7, “Internal Audits and 

Management Reviews”). 

 6.4.2 Management Reviews 

6.4.2.1 The laboratory director and manager conduct annual 

management reviews of the quality system (see Appendix H, 

AP No. 7, “Internal Audits and Management Reviews”. 

______________________________________________________________________________ 

NISTIR 7028 16 July 2003 
QM Section 6 

Page 6 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

6.4.2.2 Laboratory staff participate in the review meetings. The 

management review includes: 

6.4.2.2.1 Identification of problems that arise as a result of any 

client-discovered errors and/or discrepant results from the 

analysis of the laboratory test data (see Section 17). 

6.4.2.2.2 Evidence from internal audits and statistical control data 

and/or charts, where appropriate. (See Section 13, and 

Appendices J and N.); 

6.4.2.2.3 Evidence from proficiency tests, round robins, and/or 

interlaboratory collaborative experiments. (See Section 

13, and Appendices J and K.); 

6.4.2.2.4 Review of policies and procedures; 

6.4.2.2.5 Reports of managerial and supervisory personnel; 

6.4.2.2.6 Preventive and corrective actions; 

6.4.2.2.7 Assessments by external bodies; and 

6.4.2.2.8 Changes in volume and type of work, staff needs, facility 

and equipment needs. 

6.4.3 Authorization Review 

6.4.3.1 The laboratory submits updated authorization material annually to 

___________________ [NOTE: Insert authorization body, as 

appropriate.] for review. The material that is submitted for review 

depends upon the request from the authorization body and may 

consist of: 

a. General laboratory information; 

b. Equipment and standard information; 

c. Internal audit information; 

d. Management reviews 

e. Scope or laboratory activities;

______________________________________________________________________________ 

NISTIR 7028 17 July 2003 
QM Section 6 

Page 7 of 7 Quality System, Document Control, Internal Audits and 

Management Reviews 

f. Staff assignments and training records; and 

g. Updated quality manual 

6.4.4. All internal audit and authorization review findings, and any corrective actions 

that arise from them, are promptly settled within the agreed time, documented 

by the quality manager, and maintained in the laboratory files. 

______________________________________________________________________________ 

NISTIR 7028 18 July 2003 
QM Section 7 

Page 1 of 2 Personnel 

7.0 Personnel

7.1 Members of the laboratory staff are selected for employment based on their professional 

qualifications, including education and relevant experience (See Appendix H, AP No. 

17). The basic qualifications for type evaluation staff include: 

7.1.1 knowledge of the operation of legal for trade weighing and measuring 

instruments; 

7.1.2 experience in applying NIST Handbook 44 requirements for the inspection and 

test of commercial weighing and measuring devices; 

7.1.3 knowledge of statistics and uncertainty analysis; and 

7.1.4 completion of field weights and measures training. 

Staffing is sufficient to maintain the timely processing of the client workload, laboratory 

internal monitoring, quality control, traceability activities, and staff training. New staff is 

hired as the need arises and is trained in an on-the-job training program that ensures that 

personnel understand the metrological concepts of legal for trade weighing and 

measuring device and apply them in their testing of the devices. Laboratory managers, 

supervisors, and/or senior staff train staff on how to conduct the evaluations according to 

documented test procedures. Training is verified by the laboratory technical manager, 

who also ensures that staff is qualified to perform device testing. Additional laboratory 

training is discussed in Section 7.4. Job descriptions for laboratory personnel are 

contained in Appendix M (or are on file in the laboratory). 

Type evaluations are performed by personnel who are employed or contracted by the 

laboratory. Personnel who are in the process of training are supervised until their on-thejob training is completed. Contracted personnel are also trained or experienced in testing 

legal-for-trade weighing and measuring devices. 

7.2 Adequately trained staff is a key factor in good type evaluations. The type evaluation 

laboratory personnel have the necessary background in weights and measures and science 

as appropriate to ensure comprehension of the laboratory tests and operations. Training 

is documented and maintained in Appendix L. Procedures for identifying 

_____________________________________________________________________________ 

NISTIR 7028 19 July 2003 
QM Section 7 

Page 2 of 2 Personnel 

training needs and providing training and qualifying laboratory personnel are maintained 

in the laboratory (see Appendix H, AP No. 17). 

7.3 The laboratory supervisor(s), utilizing staff resources to meet policy goals: 

7.3.1 Implements and applies the procedures contained in the 

referenced documents as listed in Section 2; 

7.3.2 Provides ongoing training to ensure proficiency in type evaluation testing; 

7.3.3 Develops work plan schedules and requires that the staff follow the procedures in 

day-to-day operations; and 

7.3.4 Assigns and authorizes staff to perform tasks based on personnel training and 

verified competence. Records of authorizations are maintained in the laboratory 

files. (See Section 13 Records.) 

7.4 Other Training 

7.4.1 The laboratory staff attend and participate in several training opportunities to 

include the National Type Evaluation Technical Committee (NTETC) Sector 

Meetings and NTEP Laboratory Meetings. All training is documented and 

maintained in the laboratory (see Appendix L). 

 

_____________________________________________________________________________ 

NISTIR 7028 20 July 2003 
 Section 8 

Page 1 of 2 Laboratory Facilities and Environment 

8.0 Laboratory Facilities and Environment 

8.1 Facilities and Environment 

8.1.1 The laboratory facilities are maintained to support good laboratory practices and 

accurate type evaluation test results. Equipment and other items that are no 

longer used for testing are discarded or removed from the laboratory and placed 

into storage to prevent clutter in the laboratory. Portable equipment and 

materials used for testing are returned to the appropriate location (s) after use, 

and test weights are returned to storage kits. (See Appendix D, Diagram of the 

Laboratory Facilities, and Appendix H, AP No. 11.) 

8.1.2 The laboratory facilities, test areas, energy sources, lighting, heating, and 

ventilation facilitate proper type evaluation testing. The laboratory ensures that 

dust, electromagnetic interference, humidity, line voltage, temperature, and 

vibration levels (i.e., vibration sources due to surrounding equipment or 

improper support tables and temperature changes) do not affect the test and are 

appropriate for the device under test. The laboratory staff observes the device 

under test to determine if any conditions of the facility affect the test or if the 

environmental conditions are outside the limits specified in Appendix E. 

8.1.3 Environmental conditions maintained by the laboratory are appropriate for the 

type evaluation testing. The environment in the laboratory where testing is 

performed does not invalidate results nor adversely affect the test results. The 

environmental conditions of the laboratory are listed in Appendix E. The 

laboratory environmental conditions are monitored using a chart recorder, 

controlled, and recorded if required by the test procedures or if they influence 

the quality of the results. The laboratory technical manager will stop testing if

the environmental conditions jeopardize the test results (see Appendix H AP 

No. 27). The laboratory staff ensures that the facilities are adequate for testing 

by: 

8.1.3.1 verifying that air conditioning, lighting, heating, and ventilation do 

not adversely affect the environmental conditions or device being 

tested (The environmental conditions of the laboratory are as listed 

in Appendix E. See Appendix H AP No. 27.), 

_____________________________________________________________________________ 

NISTIR 7028 21 July 2003 
 Section 8 

Page 2 of 2 Laboratory Facilities and Environment 

8.1.3.2 maintaining good housekeeping practices to promote a clean, 

uncluttered laboratory according to procedures listed in Appendix H, 

AP No. 11., 

8.1.3.3 having sufficient space to minimize the risk of injury to staff and/or 

damage to standards or equipment due to activities around test setup 

(see Appendix D, laboratory diagram and dimensions), 

8.1.3.4 maintaining a convenient and efficient work environment with 

effective separation of incompatible activities (see Appendix D 

laboratory diagram and dimensions), and 

8.1.3.5 controlling access to and use of areas affecting the quality of tests 

(see QM section 18.2). 

8.2 Environmental Records 

8.2.1 Laboratory device testing 

8.2.1.1 Environmental chamber conditions are recorded with the use of a 

strip-chart recording device while testing is being conducted. The 

laboratory environmental conditions are maintained and documented 

to ensure that they are conducive to the various type evaluations. 

Corrective actions are taken when the environmental conditions 

affect the quality of test (see Appendix E, Environmental 

Conditions, and Appendix O, Complaints/Corrective Actions form). 

8.2.2 Field device testing 

 8.2.2.1 Typically field tests are not performed when the environmental 

conditions are such that they may adversely affect the test results, 

and these conditions are documented on the data sheets (see 

Appendix H, AP No. 27). 

[NOTE: Environmental monitoring devices are periodically verified against accurate and 

traceable standards.] 

_____________________________________________________________________________ 

NISTIR 7028 22 July 2003 
QM Section 9 

Page 1 of 4 Standards, Equipment, and Associated Apparatus 

9.0 Standards, Equipment, and Associated Apparatus

9.1 Laboratory standards, equipment, and associated apparatus are maintained suitable for 

the correct performance of tests and are maintained in accordance with the laboratory 

procedures (see Appendix H, AP No. 13), equipment maintenance and operational 

manuals, and this quality manual. The equipment, standards and associated apparatus are 

protected from dirt, dust, corrosion, and other causes of deterioration. The technical 

manager investigates any equipment or standards that are suspected in contributing to 

out-of-control conditions (see Appendix G, Standards List, and Appendix F, Equipment 

List). Records of corrective actions for discrepancies are maintained in the laboratory 

(see Section 13 Records, and Appendix O, Forms). Procedures for safe handling, 

transport, storage, use and planned maintenance of test equipment to ensure proper 

functioning are maintained in the laboratory (see Appendix H, AP No. 14). 

9.2 Maintenance and calibration records for equipment and standards include the following 

as appropriate (see Section 13, Records, and Appendix O, Forms): 

9.2.1 Item name and manufacturer; model, serial, and other identification numbers; 

9.2.2 Date and condition of receipt, date placed in service, and current location; 

9.2.3 History of calibration, maintenance, malfunction, modification, and repair; 

9.2.4 Calibration status, recertification date and maintenance plan, where appropriate; 

9.2.5 Identification of any software affecting the calibration and quality assurance of 

the program; 

9.2.6 Copy of manufacturer's instructions, where available; 

9.2.7 Verification that equipment complies with specifications; 

9.2.8 Verification of equipment used which is outside the control of the laboratory. 

_____________________________________________________________________________ 

NISTIR 7028 23 July 2003 
QM Section 9 

Page 2 of 4 Standards, Equipment, and Associated Apparatus 

9.3 Operation and Maintenance 

9.3.1 Equipment and Associated Apparatus 

 

9.3.1.1 Laboratory equipment is properly maintained in accordance with 

procedures for calibration, verification, and maintenance (see 

Appendix H, AP No. 14). These procedures are located in the 

laboratory files. 

 

9.3.1.2 Equipment used by the laboratory staff are handled and maintained 

in accordance with Appendix H, AP No. 14. The equipment is 

maintained so that it operates according to the manufacturer’s 

specifications for device evaluations. The following activities are 

conducted to ensure that the equipment operates according to 

manufacturers specifications: 

a. maintenance and service of the equipment by trained technicians, 

b. operation by laboratory staff that have been trained, 

c. protection from factors that may affect the operation, such as 

drafts, dirt, dust, and extreme temperatures, and 

d. when not operating correctly, labeling the equipment with an 

out-of-service tag, removing the equipment from service, and 

whenever possible storing it in the laboratory storage room (see 

Appendix D) returning it to service only when its satisfactory 

performance has been verified. 

9.3.1.3 The laboratory examines any previous tests that might have been 

affected by the equipment that was taken out of service (see 

Appendix H, AP No. 18, Procedure for Control of Nonconforming 

Work, and AP No. 14). 

9.3.1.4 Operation manuals and instructions for proper maintenance of 

equipment are available and located in the laboratory files (See QM 

Section 13 Records for location of the files in the laboratory). 

9.3.1.5 Newly installed equipment and software programs are tested to 

verify that they perform satisfactorily before they are placed into

_____________________________________________________________________________ 

NISTIR 7028 24 July 2003 
QM Section 9 

Page 3 of 4 Standards, Equipment, and Associated Apparatus 

service. Documentation of this verification is maintained in the 

laboratory (see Section 13 Records and Appendix O, Forms). The 

laboratory maintains procedures for testing newly installed 

equipment (see Appendix H, AP No. 14). 

9.3.1.6 Equipment is used only when it is in a safe and reliable condition 

and only by personnel who have been appropriately trained and are 

qualified. Safe and reliable conditions include: 

a. Stable support for equipment, 

b. Use of electrical outlets in accordance with equipment 

specifications, and 

c. loading equipment in accordance with equipment specifications. 

 

9.3.1.7 Use of equipment outside the laboratory’s control is verified prior to 

use to ensure that it meets the same requirements of the laboratory 

quality system (see Appendix H, AP No. 14). 

9.3.1.8 All equipment having an affect on the test is calibrated and is 

labelled, coded or otherwise identified to indicate the status of 

calibration, including date calibrated and recalibration due date (see 

Appendix H, AP No. 14). 

9.3.1.9 The laboratory uses and maintains procedures for the intermediate 

checks of equipment calibration status when needed (see Appendix 

H, AP No.14). 

9.3.1.10 The laboratory follows procedures to ensure that correction factors 

that arise from the calibration of equipment are correctly updated, 

including updates to any computer software data (see Appendix H, 

AP No.14). 

9.3.1.11 The laboratory ensures that test equipment is safeguarded from

adjustments that can cause invalid test results (See Appendix H, AP 

No. 14). 

9.3.2 Standards (See Section 10, Measurement Traceability and Calibration) 

_____________________________________________________________________________ 

NISTIR 7028 25 July 2003 
QM Section 9 

Page 4 of 4 Standards, Equipment, and Associated Apparatus 

9.3.2.1 To maintain integrity of the standards, all maintenance operations 

are performed according to documented procedures (see Appendix 

H, AP No. 13). The laboratory standards are: 

a. selected for use according to the level of precision, accuracy, and 

uncertainty required; 

b. limited in access and use to trained and authorized laboratory 

staff only; and 

c. handled and safely stored according to good laboratory practices. 

[NOTE: Appendix H AP No. 13 should define how Section 9.3.2.1 

a through c above are met or define your laboratory activities for 

maintaining the integrity of your standards] 

9.3.2.2 All standards having an affect on the test, are calibrated by an 

accredited or recognized laboratory with traceability to a national 

laboratory, and calibration reports are maintained in the laboratory 

files. 

[NOTE: In section 9.3.2.2, identify the calibration of your 

laboratory standards and how the calibration results are traceable to 

a national or recognized laboratory, e.g., “The laboratory standards 

of mass and volume are tested by our state metrology laboratory. 

The State metrology laboratory maintains a measurement traceability 

certificate from NIST WMD recognizing that the laboratories 

measurements are traceable to NIST (see Appendix H, AP No. 4 and 

Appendix R).]” 

_____________________________________________________________________________ 

NISTIR 7028 26 July 2003 
QM Section 10 

Page 1 of 3 Measurement Traceability and Calibration 

10.0 Measurement Traceability and Calibration

10.1 Policy 

10.1.1 Standards and measuring and test equipment significantly affecting the integrity 

of the measurements conducted by the laboratory are monitored for stability as 

part of the measurement control program. Standards and equipment are 

calibrated and/or verified before use to ensure the recall or removal from

service of any equipment or standards that are unreliable or that have exceeded 

the calibration interval. The laboratory maintains procedures for safe handling, 

transport, storage and use of reference standards, materials and equipment (see 

Appendix H, AP Nos. 13 and 14). 

10.2 Measurement Traceability 

10.2.1 Measurements of the laboratory are traceable to the international system of 

measurements (SI) through an unbroken chain of measurements. Measurement 

traceability for the laboratory test are documented in traceability charts (see 

Appendix R). 

 

10.2.2 The laboratory has a program of calibration and verification of measuring and test 

equipment that has an affect on the test results. The program is designed to 

ensure that the tests are valid and that the measurements made by the laboratory 

are traceable to national standards of measurement (see Appendix H, AP No. 14). 

10.2.3 To provide external evidence of traceability, the laboratory participates in 

interlaboratory and collaborative experiments, as available (see Appendix K and 

Appendix H, AP No. 4). 

10.3 Calibration/Verification (See Procedure for Calibration Intervals, Appendix H, AP No. 

13) 

10.3.1 Calibration of Standards

10.3.1.1 An accredited or approved laboratory with traceability to a national 

laboratory calibrates working standards.

______________________________________________________________________________ 

NISTIR 7028 27 July 2003 
QM Section 10 

Page 2 of 3 Measurement Traceability and Calibration 

10.3.1.2 Working standards are calibrated on a periodic basis, are monitored, 

and are under the custody of trained laboratory personnel (see 

Appendix H, AP No. 13). Records of the calibrations are maintained 

in the laboratory. 

10.3.1.3 Standards are recalibrated if there is damage to the standards or any 

significant change is observed in the monitoring program (see 

Appendix H, AP 13). 

10.3.1.4 If measurement traceability to SI units is not possible, there is 

traceability to certified reference materials or agreed methods and/or 

consensus standards (see Appendix H, AP No. 4). 

 

10.3.2 Verification of Standards 

10.3.2.1 Standards are continuously monitored to ensure the integrity of the 

test (see Appendix H, AP No. 13). 

10.3.2.2 Measurement assurance procedures and standard and reference 

material monitoring results are maintained in the laboratory files (see 

Appendix H, AP No. 13 and Appendix J, Control Charts). 

10.3.3 Calibration of Measuring and Test Equipment (M&TE) 

10.3.3.1 Type evaluation test equipment that might affect test results is 

calibrated by a national laboratory, or by a laboratory whose 

traceability to a national laboratory has been validated through a 

verification process. A calibration interval is established for the 

equipment and the equipment is labeled, marked, or otherwise 

identified to indicate its calibration status (see Appendix H, AP No. 

14). 

10.3.3.2 Procedures for setting and changing M&TE calibration intervals are 

maintained in the laboratory files (see Appendix H, AP No. 14). 

10.3.3.3 Calibration of equipment is conducted at a frequency to ensure that 

the equipment remains in tolerance during its use in the laboratory.

______________________________________________________________________________ 

NISTIR 7028 28 July 2003 
QM Section 10 

Page 3 of 3 Measurement Traceability and Calibration 

Frequency of calibration is based on a review of calibration, 

maintenance, and repair history. The technical manager conducts 

reviews and the records of the review are maintained with the 

internal audit records in the laboratory files (see Appendix H, AP 

No. 14). 

10.4 Measurement of Uncertainty 

10.4.1 The laboratory is a type evaluation laboratory that performs testing and evaluation 

of weighing and measuring devices. A variety of tests are performed on each 

device under test to include accuracy, influence factors, and permanence testing. 

The laboratory identifies all components of the test uncertainty that might affect 

the integrity of the test results, makes a reasonable estimation, and ensures that 

the form of reporting the results does not give a wrong impression of the 

uncertainty. NIST Technical Note 1297 “Guidelines for Evaluating and 

Expressing the Uncertainty of NIST Measurement Results and the ISO Guide to 

the Uncertainty in Measurement are used as the basis for the expression of 

uncertainty in measurement (see Appendix I, “Assessment of Uncertainties”). 

______________________________________________________________________________ 

NISTIR 7028 29 July 2003 
QM Section 11 

Page 1 of 3 Type Evaluation Test Methods and Procedures 

11.0 Type Evaluation Test Methods and Procedures

11.1 The administrative and test procedures are maintained in the laboratory files. The 

procedures are available to the laboratory staff and are followed to ensure the integrity of 

the test results, and that the administrative and test procedures are conducted uniformly in 

the laboratory (see Appendix H, Procedures List). Equipment manuals, operating 

instructions, reference data, specifications, and tolerance tables relevant to the laboratory 

are maintained in an up-to-date file in the laboratory and are readily available. 

11.2 The selected test procedures are appropriate for the device under test, and the latest 

edition of the procedure is used to test the device. When documented or published 

procedures are unavailable, or when deviations from documented procedures occur, 

procedures for a specific test are developed, validated, and agreed to by the laboratory 

and the type evaluation body. The extent of the validation meets the needs of the 

application. The results of the validation are maintained in the laboratory and include the 

validation procedures used and a statement that the method is fit for its intended use (see 

Appendix H, AP No. 19 and Section 13, Records). Before a new test is conducted, the 

laboratory reviews the test procedure to ensure that the test can be performed adequately. 

 If the test procedure is revised, the review is repeated. The test report states the 

procedure used to perform the test. Records regarding departures from documented 

policies and procedures or from standard specifications are initiated by laboratory 

management and are maintained in the laboratory files (see Section 13, Records and 

Appendix O, Forms). Procedures for departure from documented policies and procedures 

are maintained in the laboratory (see Appendix H, AP No. 15 and AP No. 19). 

11.3 Type Evaluation Testing Procedures 

11.3.1 The laboratory follows the procedures and checklist in NCWM Publication 14 

(see Appendix H, Measurement Procedures List). 

11.3.2 The type evaluation procedures of NCWM Publication 14 include specific 

technical policy and specific references to NIST HB 44. 

11.3.3 The laboratory identifies all the components of the uncertainty that might affect 

the integrity of the test results in accordance with the NIST TN 1297 and the 

ISO Guide to the Uncertainty in Measurement. The device under test must meet

______________________________________________________________________________ 

NISTIR 7028 30 July 2003 
QM Section 11 

Page 2 of 3 Type Evaluation Test Methods and Procedures 

the tolerances and specifications of NIST HB 44 according to the test methods 

of NCWM Publication 14 (and/or must meet the tolerances and specification of 

OIML recommendations). Type evaluations of weighing and measuring devices 

are conducted by using standards to verify the accuracy of the device and other 

tests are performed to ensure that the device meets the required specifications. 

Laboratory staff are trained before they may conduct the test. Test methods and 

reporting instructions are followed when conducting the test (see Appendix H, 

measurement procedures list).

11.4 Administrative Procedures 

11.4.1 The administrative procedures required by ISO/IEC 17025 are developed by the 

laboratory and listed in Appendix H. Additional administrative procedures are 

located in NCWM Publication 14 and are maintained in the laboratory. The 

administrative procedures ensure that the overall operations of the laboratory 

promote the quality and integrity of the test results and test items. 

11.4.2 The technical manager maintains the procedures for the purchase, receipt and 

storage of consumable materials used for the technical operations of the 

laboratory (see Appendix H, AP No. 9). 

11.5 Control of Data 

11.5.1 As a minimum, laboratory staff review data, calculations, and test results to 

ensure the integrity of the type evaluation. Checks or quality control procedures 

include interlaboratory or proficiency testing and replicate tests or retesting, as 

appropriate for the device under test. Records are maintained regarding 

feedback and corrective action whenever testing discrepancies are detected. 

(See Section 13 Records, Appendix O, Forms, Appendix H, AP No. 6, 

Feedback, Corrective and Preventive Actions, Appendix H, AP No. 20, 

Monitoring the Validity of Test Results and Appendix H, AP No. 8 Control of 

data and Software Data Integrity.) Where computers are involved in data 

recording, retrieval, processing, calculation, analysis, or reporting, the 

laboratory ensures that: 

11.5.1.1 The requirements of this manual are maintained; 

______________________________________________________________________________ 

NISTIR 7028 31 July 2003 
QM Section 11 

Page 3 of 3 Type Evaluation Test Methods and Procedures 

11.5.1.2 Computer software developed by the laboratory has been 

documented and verified by using data sets. (See Section 13 

Records and Appendix O, Forms); and 

11.5.1.3 Computer equipment is maintained in accordance with the 

procedures for maintenance of equipment (see Appendix H AP 14) 

and is used in suitable environmental and operating conditions. 

11.5.2 The laboratory procedure for software data integrity, Appendix H, AP No. 8, 

includes guidance on how to: 

11.5.2.1 Protect the integrity and confidentiality of stored test data, test data 

entry or collection; 

11.5.2.2 Limit access to maintain security of the programs in use; 

11.5.2.3 Backup programs and test records; 

11.5.2.4 Revise the software if updates occur; 

11.5.2.5 Protect test data transmission and processing. 

11.5.3 The technical manager maintains the procedures for software documentation 

and verification, which are located in the laboratory files (see Appendix H, AP 

No. 8). 

______________________________________________________________________________ 

NISTIR 7028 32 July 2003 
QM Section 12 

Page 1 of 2 Handling and Storage of Test Items 

12.0 Handling and Storage of Test Items

12.1 Items received for test are recorded in a laboratory work log and assigned a number that 

uniquely identifies the item during its stay in the laboratory. Work logs are maintained 

in the laboratory. A work order is completed to include: the item or items received for 

test, name of company submitting the test items, and date of receipt. Work orders are 

attached to and, if possible, are kept with the test item during its stay in the laboratory 

(see Appendix O, “Forms,” Section 13 Records, and Appendix P, Type Evaluation 

Process Flowcharts, Appendix H, AP No. 5, Handling Calibration and Test Items). 

12.2 Incoming test items are evaluated by laboratory staff to ensure that standards, equipment, 

staff, facilities, and procedures necessary to perform testing are available. Procedures for 

the review of all incoming work are maintained in the laboratory files (see Appendix H, 

AP No. 5.). 

12.3 Prior to testing incoming items, the laboratory communicates to the client any significant 

abnormalities (see Appendix H, AP No. 5) including: 

12.3.1 Departures from required standard conditions and necessary preparations; 

12.3.2 Doubt as to the test items suitability for testing; and 

12.3.3 Nonconformance of the test item with the description (application information) 

provided by the client. 

Records of these client discussions are maintained in the laboratory (see QM Section 13, 

Records) 

12.4 The laboratory handles, prepares, and stores test items in its custody in a safe manner to 

protect them from loss, deterioration, damage, and destruction of required chains of 

evidence. Documented procedures for the receipt and retention of the test items are 

maintained in the laboratory files (see Appendix H, AP No. 5). 

12.5 If a test item requires specific environmental conditions for storage, the conditions are 

maintained, monitored and recorded (see Appendix H, AP No. 5). 

12.6 Test items to be held for any reason, including safety, value, to perform check testing, 

etc., are stored and secured to protect the item’s condition (see Appendix H, AP No. 5).

______________________________________________________________________________ 

NISTIR 7028 33 July 2003
QM Section 12 

Page 2 of 2 Handling and Storage of Test Items 

12.7 Upon completion of testing, the test items will be retained no longer than necessary, and 

will be safely returned to the client. (See Appendix H, AP No. 5, The Return of Test 

Items, which includes procedures for shipping.) 

______________________________________________________________________________ 

NISTIR 7028 34 July 2003
QM Section 13 

Page 1 of 4 Records 

13.0 Records

13.1 The laboratory maintains procedures for the identification, collection, indexing, access, 

filing, storage, maintenance and disposal of administrative and measurement-related 

records. All records are readily retrievable and maintained in a suitable environment. 

(See Appendix H, AP No. 22.) 

13.2 To ensure that the laboratory records are secure and to prevent destruction or tampering, 

the laboratory records are kept in locked cabinets and access to the files are limited to the 

laboratory staff. Records include information required by regulation or associated with 

original test observations, calculations, and reported results. Type evaluation data is 

recorded in permanent form at the time of test, in bound notebooks, or on standard forms 

on file (see Appendix O, Forms). Permanent ink is used to record the actual data, and no 

erasures or whiteouts are made. Any corrections to data are made by drawing a single 

line through the entry and initialing the change with a note as to why the change was 

made. The type evaluation test number is included on the data sheets to ensure that the 

data and calculations are identifiable to the specific job. Type evaluation records contain 

sufficient detail to permit any necessary repetition of the evaluation and identification of

the components of uncertainty. Records of original data include the following: 

13.2.1 Test Procedure used; 

13.2.2 Description of, and reason for, any deviation from the standard operating 

procedure (SOP); 

13.2.3 Identity of the personnel performing testing; 

13.2.4 Identity and description of objects under test; 

13.2.5 Identity of equipment or apparatus used; 

13.2.6 Identity of standards used and reference to traceability; 

13.2.7 Date of test; 

13.2.8 Original test data;

_____________________________________________________________________________ 

NISTIR 7028 35 July 2003
QM Section 13 

Page 2 of 4 Records 

13.2.9 Derived data; 

13.2.10 Type evaluation control number and State test number if appropriate; 

13.2.11 Environmental data during test when applicable (see Section 8 Laboratory 

Facilities and Environment); and 

13.2.12 Work order. 

13.3 Records, including those in computer files, are accessible only to authorized personnel. 

Computer files are backed-up for protection against loss (see Appendix H, AP No. 22 

Record Maintenance). [NOTE: Include a brief explanation of how your files are backedup and how access to your electronic records are controlled.] 

13.4 Two categories of records are maintained by the laboratory: administrative and 

measurement-related. The laboratory maintains and retains the following records in the 

locations stated for the specified amount of time. [Note: Laboratories should include a 

statement addressing the specific retention time of records according to State or 

laboratory policy.]

_____________________________________________________________________________ 

NISTIR 7028 36 July 2003
QM Section 13 

Page 3 of 4 Records 

 

Administrative 

List of Records Location Retention Time 

Audit 

Complaints/ Feedback/ Preventive and 

Corrective Action 

Deviations from Accepted Procedure 

Management Review 

List of Approved Signatories 

Subcontractors and Outside Suppliers 

(evidence of compliance to the quality 

system) 

List of Key Personnel Performing Other 

Duties 

Controlled Document Distribution List 

Personnel Training and Competency 

Contract (Application) Review and 

Client Discussions 

Internal Audits 

Validation of Test Methods 

Management Staff Authorization and 

Assignment for Testing 

Inspection and Verification of Support 

Services and Supplies and Resulting 

Actions 

_____________________________________________________________________________ 

NISTIR 7028 37 July 2003
QM Section 13 

Page 4 of 4 Records 

 

Measurement-Related 

List of Records Location Retention Time

Test Reports (Certificates)* and 

Amendments to Test Reports 

(Certificates) 

Original Test Data 

Environmental Conditions/Deviations 

Log 

Calibration and Maintenance 

(Standards and Equipment) 

Software Verification 

Working Standards Calibration Reports

Equipment Assessment 

Assessment of Uncertainties 

Interlaboratory/Proficiency Test Results

Equipment Operation and Instruction 

Manuals 

*Certificates are Certificates of Conformances (CC) 

_____________________________________________________________________________ 

NISTIR 7028 38 July 2003
QM Section 14 

Page 1 of 4 

Type Evaluation Test Reports 

(Certificates of Conformance) 

14.0 Type Evaluation Test Reports (Certificates of Conformance)

14.1 Type evaluation tests reports (Certificates of Conformance) are reviewed by the 

laboratory staff to correct any inconsistencies in the report, supporting data, and 

calculations (see Section 13 Records for the location of calibration and test reports). 

Upon successful completion of testing, the laboratory drafts a Certificate of Conformance 

(CC) based on the test results. The CC is reviewed by the device manufacturer, the 

laboratory technical manager, and the type evaluation manager before issuance (see 

Appendix P, page 5 of 10). The CC contains the results from the test report. 

14.2 If accredited by NVLAP, the laboratory follows the NVLAP policy (NIST HB 150 Annex 

A) regarding the use of the NVLAP logo, (see Appendix H, AP No. 25). 

14.3 Test results and data are reported accurately, clearly, unambiguously and objectively in 

accordance with any specific instructions in the test methods. 

The test results are initially provided in a test report, and information from the test report 

is included in a CC. The test report includes all information requested by the client as 

appropriate in accordance with the test procedures and necessary for the interpretation of 

the test results and required by the method. If tests are performed for internal clients, or 

as requested in a written agreement with the client, the test results are reported in a 

simplified way, but all information that is usually included in the test report is available 

in the laboratory. 

14.4 Any opinions and interpretations included in test reports are clearly marked as such and 

indicate the basis upon which the opinions and interpretations were made. Any opinions 

and interpretations that are communicated through conversation with the client are 

documented on the test report. 

14.5 Test reports (Certificate of Conformance) include the following information: 

[NOTE: Laboratories should edit this section following the guidelines in ISO/IEC 

17025 Section 5.10.2 and 5.10.3.] 

14.5.1 A report title; 

14.5.2 Name and address of the laboratory and location where the test was conducted 

if different from the laboratory; 

______________________________________________________________________________ 

NISTIR 7028 39 July 2003 
QM Section 14 

Page 2 of 4 

Type Evaluation Test Reports 

(Certificates of Conformance) 

14.5.3 Unique identification of the test (CC Number) on every page of the CC, 

identification which shows the end of the page, and page number and total 

number of pages; 

14.5.4 Name and address of client; 

14.5.5 Item identification including: description, manufacturer, model, and serial 

number (where available); 

14.5.6 Test date; 

14.5.7 Condition and characterization of the item (where relevant); 

14.5.8 Identification of the test method used; 

14.5.9 Additions, exclusions or deviations from the test method and other relevant 

information including environmental conditions existing during test (when 

applicable); 

14.5.10 Tables, graphs, and other supporting information when necessary for the 

interpretation of the report; 

14.5.11 Test results with units of measure and accuracy and tolerance conformity as 

appropriate. 

14.5.12 Date of issue and signature of the technical manager, laboratory staff, or other 

official who accepts responsibility for the validity of the results and the content 

of the report; 

14.5.13 Where relevant, a statement that the report relates only to the items listed in the 

report “at the time of test;” 

14.5.14 The estimated uncertainty if the uncertainty affects compliance to specification 

limits; 

14.5.15 Clear identification of reported results or test if performed by subcontractors; 

______________________________________________________________________________ 

NISTIR 7028 40 July 2003 
QM Section 14 

Page 3 of 4 

Type Evaluation Test Reports 

(Certificates of Conformance) 

14.5.16 Where relevant, reference to sampling procedures, date of sampling, 

identification of samples, sampling location, environmental conditions, during 

sampling, that can affect the test results, and standards or specifications for 

 sampling. 

14.5.17 A statement that the CC shall not be reproduced, except in full, without the 

written approval of the laboratory; 

14.5.18 Statement that the client shall not use the report to claim product endorsement 

by the laboratory accrediting body, as appropriate; 

14.5.19 Signature of an approved signatory for all test and calibration reports endorsed 

with the accreditation status or NVLAP logo (see Section 13 Records, List of 

Approved Signatories); 

14.5.20 Special limitations of use; 

14.5.21 Traceability statement, as appropriate; 

14.5.22 Date test item received, test complete and draft CC complete (this information 

is kept on file; not placed on the CC); and 

14.5.23 Opinions and interpretations, and any additional information required by the test 

method, where appropriate. 

14.6 The laboratory follows a failure process and procedures to address tests or test results 

that do not conform to the test requirements (see Appendix P). The procedures ensure 

that: 

14.6.1 Management responsibilities and authorities for addressing nonconforming 

work and the actions to be taken are identified; 

14.6.2 The significance of the nonconformance is evaluated; 

14.6.3 Remedial actions are addressed and decision are made quickly; 

14.6.4 The client is notified and the work is recalled;

______________________________________________________________________________ 

NISTIR 7028 41 July 2003 
QM Section 14 

Page 4 of 4 

Type Evaluation Test Reports 

(Certificates of Conformance) 

14.6.5 Persons responsible for authorizing the work to continue are identified; and 

14.6.6 When there is indication that non-conforming work could recur, the laboratory 

follows the corrective action procedure (see Appendix H, AP No. 18). 

14.7 The laboratory notifies its customers in writing of any events that cast doubt on the 

validity of the results given in any test report or amendment to a report. 

14.8 Amendments are made in the form of an additional document or data transfer and the 

Certificate is labeled with an amendment number for each amendment (e.g., A1, A2, 

A3. . .). If a new document is issued, it contains a reference to the original that it 

replaces. Records of these documents are maintained by the laboratory staff and located 

in the laboratory files (see Section 13 Records, Test Reports (Certificates)/Supplements 

to Test Reports (Certificates). 

14.9 Tests performed by subcontractors are clearly identified on the test report by including a 

note that states the data and results were received from a subcontractor (see QM Section 

15). [NOTE: Edit QM section 14.9 to describe how your laboratory would identify 

subcontracted work on a test report; delete this section if you do not subcontract.] 

14.10 Opinions and interpretations are clearly identified on the test report by writing notes on 

the test report adjacent to the test results for each test of the device, which includes the 

basis upon which the opinions and interpretations are made. 

14.11 When test results are transmitted by telephone or electronically the procedures for the 

control of data are followed (see QM Section 11.5 and Appendix H, AP No. 8). 

14.12 The test reports (certificates) are clear and understandable. The test report formats are 

included in NCWM Publication 14 (see QM Section 2, References and Definitions). 

______________________________________________________________________________ 

NISTIR 7028 42 July 2003 
QM Section 15 

Page 1 of 1 Subcontracting 

15.0 Subcontracting

15.1 The laboratory performs tests within its documented capability. The laboratory 

does not subcontract. 

 OR 

15.1 The laboratory subcontracts in the special circumstances where technical, safety, or 

efficiency issues dictate. Subcontracting is only conducted with authorized type 

evaluation laboratories or State Weights and Measures officials capable of performing 

type evaluation testing. The laboratory maintains a list of all subcontractors used by the 

laboratory, along with evidence of their compliance to the laboratory’s quality system

(see Section 13 Records). 

15.2 The laboratory is responsible for the subcontractor’s work and notifies the client in 

writing of the arrangements for subcontracting. 

15.3 The laboratory receives the subcontractor’s data in writing or electronically. The data is 

included in the test report and is identified with a note that states that the data was 

received from a subcontractor. [NOTE: Edit QM section 15.3 to describe how your 

laboratory would identify subcontracted work. If NVLAP accredited, follow the 

requirements of NVLAP as found in NIST Handbook 150.] 

______________________________________________________________________________ 

NISTIR 7028 43 July 2003 
QM Section 16 

Page 1 of 1 Outside Support Services and Supplies 

16.0 Outside Support Services and Supplies

16.1 The laboratory uses services and supplies of adequate quality where the specifications of 

outside services and supplies are relevant to the integrity of tests. The laboratory 

maintains procedures for the purchase, storage, and evaluation of supplies and services 

(see Appendix H, AP No. 9). 

16.2 The purchasing orders contain data that describe the services and supplies ordered; they 

are reviewed and approved before release. The technical manager completes the 

purchasing order, which includes the following information: 

16.2.1 description of the service or supply, 

16.2.2 service provider or supplier name address and phone number, 

16.2.3 cost of the service or supply, and 

16.2.4 date of request. 

The technical manager reviews the purchase order and the director approves the order 

before it is released. 

16.3 Where assurance of the quality of outside support services or supplies is unavailable, the 

laboratory uses these items only after they have been inspected or otherwise verified for 

adequate quality. The suppliers of critical supplies and services that affect the quality of

testing are evaluated. The technical manager, upon receipt of the service or supply, 

examines the supply or quality of the service and records the findings on the “Inspection 

and Verification of Support Services and Supplies and Resulting Action Form.” If the 

services or supplies are not of adequate quality, the procedure for the control of nonconforming work is initiated (see Appendix H, AP No. 18). The records of inspections, 

and verification of suppliers and services and actions are maintained in the laboratory 

(see Appendix H, AP No. 9 and Section 13 Records). 

______________________________________________________________________________ 

NISTIR 7028 44 July 2003 
QM Section 17 

Page 1 of 2 Preventive Action / Complaints and Corrective Action 

17.0 Preventive Action / Complaints and Corrective Action

17.1 Preventive Action 

17.1.1 The laboratory participates in annual NTEP laboratory meetings. Discussion at 

these meetings includes the interpretation of type evaluation test procedures. 

The information from these meetings is documented and used to improve the 

quality of test in the laboratory. The laboratory obtains information from

laboratory meetings and internal reviews and uses this information to examine 

its technical and quality system to identify needed improvements and potential 

sources of nonconformance. If preventive action is required, action plans are 

developed, implemented, and monitored. Procedures for preventive action are 

maintained in the laboratory (see Appendix H, AP No. 6). 

[NOTE: If the laboratory has a control chart process, this can be referenced in 

this section as a means of preventive action] 

 

17.2 Complaints and Corrective Action 

17.2.1 The laboratory promptly investigates complaints, adverse findings during 

audits, or any other circumstance that raises doubts concerning the laboratory's 

competence or compliance with required procedures. The laboratory determines 

the root cause, identifies potential corrective actions, and follows a corrective 

action procedure to resolve the adverse situation promptly and, where 

necessary, conducts a retest. Procedures for handling complaints are 

maintained in the laboratory (see Appendix H, AP No. 6, AP No. 10, and AP 

No. 16). 

17.2.2 The laboratory quality manager examines all documents and records associated 

with complaints, and the laboratory technical manager investigates adverse 

audit findings and other circumstances. If deficiencies are discovered during 

these reviews, they are documented. After review of the deficiencies with the 

laboratory staff and management, corrective actions are documented for each 

deficiency appropriate to the magnitude and risk of that deficiency and likely to 

eliminate or prevent recurrence. Deadlines are set for each corrective action. 

The laboratory manager monitors the corrective action to ensure that it is 

effective (see Appendix H, AP No. 6).

______________________________________________________________________________ 

NISTIR 7028 45 July 2003 
QM Section 17 

Page 2 of 2 Preventive Action / Complaints and Corrective Action 

17.2.3 Records of deficiencies and corrective actions are maintained in the laboratory 

(see Section 13, Records and Appendix O, Forms). 

______________________________________________________________________________ 

NISTIR 7028 46 July 2003 
QM Section 18 

Page 1 of 2 Site Security 

18.0 Site Security

18.1 The laboratory is located within the Weights and Measure Department. Security of the 

State facilities is the responsibility of the building manager and State contracted security 

and is subject to the security requirements of the Weights and Measures Department. The 

laboratory technical manager is responsible for security directly related to the laboratory 

and designates the specific duties of on-site security to the laboratory staff. Security of 

the laboratory premises includes the following: 

18.1.1 Locking laboratory doors in specific areas when not in use; 

18.1.2 Securing all doors and perimeter at the close of the day; 

18.1.3 Notifying building security of disturbances and suspicious activity as 

appropriate; 

18.1.4 Securing entrances to the laboratory when disturbance during testing affects the 

integrity of the type evaluation; and 

18.1.5 Securing all areas where standards and equipment are stored or maintained. 

18.2 Access 

18.2.1 Access to and use of all type evaluation areas are controlled and defined by the 

technical manager. The laboratory maintains the current access list as follows: 

[NOTE: Replace Area 1 and Area 2 with a specific measurement area and list the 

staff (laboratory or support) that has access to the specific area.] 

Access 

Staff Area 1 Area 2 Computers 

1 X X X 

2 X X 

3 X X 

______________________________________________________________________________ 

NISTIR 7028 47 July 2003 
QM Section 18 

Page 2 of 2 Site Security 

18.2.2 Laboratory building keys are given to administrative staff members and 

laboratory personnel. 

18.2.3 Cleaning staff has supervised access to the laboratory during normal working 

hours. 

______________________________________________________________________________ 

NISTIR 7028 48 July 2003 
QM Section 19 

Page 1 of 1 Safety 

19.0 Safety

19.1 Safe working conditions are prerequisite to good laboratory practices. Laboratory 

personnel are instructed in safe working practices and are encouraged to look for 

hazardous conditions and repair or report them to the quality manager, as well as to 

recommend and implement accident prevention. The quality manager documents 

hazardous conditions and the actions taken to eliminate the hazardous condition. 

19.2 The laboratory maintains a safety manual on file in the laboratory. The safety manual is 

available to all laboratory staff and management and contains all safety regulations 

associated with the overall laboratory operations (see Appendix N, Document Control). 

19.3 Management provides safe-working conditions, complies with safety regulations, and, 

along with supervisors, ensures that the staff complies with these regulations. 

19.4 It is the responsibility of all staff to be familiar with and comply with all safety guidelines 

and requirements. The laboratory staff takes proper precautions in the laboratory as 

described in the safety manual.

______________________________________________________________________________ 

NISTIR 7028 49 July 2003 
QM Section 20 

Page 1 of 1 Sampling 

20 Sampling 

20.1 The laboratory does not use sampling as part of the type evaluation testing. 

OR 

20.1 The laboratory applies sampling procedures for substances, materials or product for type 

evaluation testing. A sampling plan and procedure are available at the location where 

sampling is undertaken (see Appednix H, AP No. 23). The sampling plan is based on 

appropriate statistical methods, and the process addresses the factors that must be 

controlled to ensure valid test results.

[NOTE: When sampling, a part of a substance or material is taken as a representative 

sample of the whole to provide for testing. Sampling procedures may be necessary for 

devices such as grain moisture meters. The laboratory should briefly describe in section 

20.1 how sampling plans are developed or chosen for a particular application.] 

20.2 Records are maintained of any client-requested deviations, additions or exclusions from

the documented sampling procedure and are reported in the test results. The laboratory 

maintains procedures for recording to include the sampling procedure used, the 

identification of the sampler, environmental conditions (if relevant) and the diagrams or 

other equivalent means to identify the sampling location as necessary, and, if appropriate, 

the statistics the sampling procedures are based upon. (See Appendix H, AP No. 23.) 

____________________________________________________________________________________________

NISTIR 7028 50 July 2003 
Appendix A 

Page 1 of 2 Definitions 

Authorization - a formal recognition that a laboratory is competent to carry out specific tests. 

 

Corrective Action - an action taken to eliminate the causes of an existing deficiency or other 

undesirable situation in order to prevent recurrence. 

Deficiency - the nonfulfillment of an accrediting or authorization body’s conditions and/or 

criteria for accreditation or authorization. 

Internal Audit - systematic and documented process for obtaining evidence and evaluating it 

objectively to verify that a laboratory’s operations comply with the requirements of its quality 

system. [NIST HB 150] 

Interlaboratory Comparisons - organization, performance, and evaluation of tests on the same

or similar items or materials by two or more laboratories in accordance with predetermined 

conditions. [ISO/IEC Guide 43-1:1997, 3.7 expanded] 

NVLAP - the National Voluntary Laboratory Accreditation Program, a part of NIST 

OWM - the Office of Weights and Measures, a part of NIST. 

Preventive Action - an action taken to eliminate the causes of a potential deficiency or other 

undesirable situation in order to prevent occurrence. [NIST HB 143] 

Proficiency Testing - determination of laboratory testing performance by means of 

interlaboratory comparisons. [ISO/IEC Guide 2:1996, 13.5] 

Standard, Primary - Standard that is designated or widely acknowledged as having the highest 

metrological qualities and whose value is accepted without reference to other standards of the 

same quantity. [VIM:1993, 6.4] 

Standard, Reference - Standard, generally of the highest metrological quality available at a 

given location or in a given organization, from which measurements made at that location are 

derived. [VIM:1993, 6.6]

______________________________________________________________________________ 

NISTIR 7028 51 July 2003 
Appendix A 

Page 2 of 2 Definitions 

Standard, Secondary - Standard whose value is assigned by comparison with a primary 

standard of the same quantity. [VIM:1993, 6.5] 

Standard, Working - Standard that is used routinely to calibrate or check material measures, 

measuring instruments, or reference materials. [VIM:1993, 6.7, without notes] 

Traceability - the property of a result of a measurement or the value of a standard whereby it can 

be related to stated references, usually national or international standards, through an unbroken 

chain of comparisons all having stated uncertainties. [VIM:1993, 6.10, without notes] 

Uncertainty of Measurement – parameter, associated with the result of a measurement, that 

characterizes the dispersion of the values that could reasonably be attributed to the measurand. 

[VIM:1993, 3.9, without notes] 

Uncertainty, Type A (evaluation of) - method of evaluation of uncertainty by the statistical 

analysis of series of observations. [GUM:1993, 2.3.2] 

Uncertainty, Type B (evaluation of) - method of evaluation of uncertainty by means other than 

the statistical analysis of series of observations. [GUM:1993, 2.3.3] 

Verification - confirmation by examination and provision of evidence that specified 

requirements have been met. [ISO 8402:1994, 2.17, without notes] 

______________________________________________________________________________ 

NISTIR 7028 52 July 2003 
Appendix B 

Page 1 of 2 Organization Charts 

 Weights and Measures Department 

M r. T . J o h n s o n

D ire c to r

T u rf and S eed

M s . A . J o nes

D ire c to r

A n im a l In s p e c tio n

W e 

D r. W .A .M e a s u re s

D ire c to r

M r. T . G re g g s

In s p e c to r I M s . G . H o lm e s In s p e c to r II M s . F . S is s o n In s p e c to r III M s . M . M in e s In s p e c to r II 

T 

M s . S . H a ir s to n

T e c h n ic a l

M ana ger

M s . G . T e rry

T e c h n ic ia n

A lt. T e c h n ic a l

M ana ger

M s . S . C la y to n

T e c h n ic ia n

__________________________________________________________________________________________NISTIR 7028 53 
Appendix B 

Page 2 of 2 Organization Charts 

 Weights and Measures NTEP Laboratory 

M s . D . O ls e n

D ire c to r

W e ig h ts and

M eas u re

M s . G. Go re

P ro g ra m

M a n a g e r

T y p e E v a luatio n

Lab o ra to ry

M s . S . H a irs to n

T e c h n ic a l

M ana g e r

M s . W . L e v y

Q u a lity M a n a ger

M s . G . T e rry

T e c hnic ia n

A lt. T e c h n ic a l

M ana g e r

M s . S . C la y to n

T e c hnic ia n

M r. S . W illia m s

T e c hnic ia nA lt. Q u a lity

M a n a ger

___________________________________________________________________________________________NISTIR 7028 54 
Appendix C 

Page 1 of 2 Measurement Parameters 

[NOTE: Edit this table to include the devices that are tested in your laboratory.] 

Scope of U.S. Type Evaluation Authorization 

Device Type Range Device Type Range

Type Evaluate Weighing and Other Associated 

Devices to include: 

Type Evaluate Liquid Measuring and Other 

Associated Devices to include:

 automatic weighing 

 systems

 LPG meter

 axle-load retail motor fuel 

 consoles

 belt conveyor retail motor fuel 

 controllers

 counter retail motor fuel 

 dispensers

 bulkweigher retail motor fuel 

 registers

 crane

 retail motor fuel 

 systems

 floor vehicle tank meter

 grain test wholesale meter

 hanging wholesale VTM 

 hopper wholesale controller 

 indicating element Indicators/ECR's with 

 Measuring Devices1

 jeweler's Mass Flow Meters

 livestock Other(s)_________

 on-board weighing 

 system Type Evaluate Linear Measuring Devices to include:

 POS mechanical taximeters

 postal electrical taximeters

 prepackaging Type Evaluate Grain Moisture Meters to include:

 dielectric

 near infrared

 prescription Type Evaluate Grain Protein or Other Constituents 

Devices to include:

 grain protein

 other 

 constituent______

 other 

 constituent______

______________________________________________________________________________ 

NISTIR 7028 55 July 2003 
Appendix C 

Page 2 of 2 Measurement Parameters 

Scope of U.S. Type Evaluation Authorization

Device Type Range Device Type Range

Type Evaluate Weighing and Other Associated 

Devices to include: 

Field/Perm Test all Liquid Measuring Devices to 

include: 1

 shipping indicators with 

 measuring devices

 vehicle1 mass flow meters

 weight classifier Field/Perm Test Weighing Devices to include: 1

 wheel-load weigher1 test medium capacity 

 scales

 indicators/ECR's with 

 scales1 Field/Perm Test Weighing Devices to include: 1

 automatic bulk 

 weighing systems

1

 test large capacity 

 scales

 load cells (inc. 

 influence factors)

 test railroad track 

 scales

 perform influence 

 factor testing test hopper scales

 other___________ belt-conveyor scales

Type Evaluate Devices (Per OIML Requirements)

 add models to 

 Certificates of 

 Conformance

 nonautomatic 

 weighing instruments

N/A

 load cells

 cross-reference 

 products between 

 Certificates of 

 Conformance

 make corrections to 

 Certificates of 

 Conformance

N/A

 other(s)_________ N/A

1

 Type evaluate and generate Certificates of Conformance but may include field permanence testing by other 

authorized laboratories.

______________________________________________________________________________ 

NISTIR 7028 56 July 2003 
Appendix D 

Page 1 of 1 Diagram of Laboratory Facilities 

 

Sample Diagram [NOTE: Include a diagram of your type evaluation laboratory in this 

Appendix.] 

Offices and Storage 

Offices

Type 

Evaluation

Weighing

Lab

Type 

Evaluation

Measuring 

Lab

Time

Small

Package

Small

Volume

Grain

Mass

Tolerence

Testing

Small 

Mass

Precision

Large Mass Large Volume

Loading 

Platform

Paint 

Room

Environmental 

Chamber

Type Evaluation 

Device Storage 

Room

Laboratory Dimensions 

Laboratory Dimensions (Length and Width)

________________________________________________________________________________ 

 NISTIR 7028 57 July 2003 
Appendix E 

Page 1 of 1 Environmental Conditions 

[NOTE: Specify what needs to be controlled or monitored and the limits] 

Location / Test Type

Environmental Conditions

Temperature EC/ 

Relative Humidity % 

Within " EC Other Environmental 

Factors 

___________________________________________________________________________________________NISTIR 7028 

58
Appendix F 

Page 1 of 2 Equipment and Materials 

[NOTE: List laboratory equipment] 

Equipment List 

Equipment Model and Serial No. Location 

Environmental Equipment List 

Equipment Model and Serial No. Location 

______________________________________________________________________________ 

NISTIR 7028 59 July 2003 
Appendix F 

Page 2 of 2 Equipment and Materials 

Associated Equipment and Materials List 

Equipment Model and Serial No. Location 

______________________________________________________________________________ 

NISTIR 7028 60 July 2003 
Appendix G 

Page 1 of 1 Standards and Reference Materials 

[NOTE: List the laboratory standards and reference material and location in the laboratory.] 

Working Standards List 

Type Item SI (Metric)/ 

Inch-Pound 

Location 

Reference Materials List 

Item Location 

NISTIR 7028 61 July 2003 
Appendix H 

Page 1 of 4 Procedures List 

[ Note: List your laboratory procedures in this section.] 

NCWM Publication 14, Administrative Procedures, Technical Policy, Checklist and Test Procedures 

No. Administrative Procedures 

NISTIR 7028 62 July 2003
Appendix H 

Page 2 of 4 Procedures List 

NCWM Publication 14, Administrative Procedures, Technical Policy, Checklist and Test Procedures, 

Current Edition 

No. Administrative Procedures 

NISTIR 7028 63 July 2003
Appendix H 

Page 3 of 4 Procedures List 

NCWM Publication 14, Administrative Procedures, Technical Policy, Checklist and Test Procedures 

No. Test Procedures and Checklists 

No. OIML Recommendations 

NISTIR 7028 64 July 2003
Appendix H 

Page 4 of 4 Procedures List 

[NOTE: The procedures in this list are those that are required by ISO/IEC 17025. The quality manual makes reference to the procedures in this 

list. List all the laboratory administrative procedures in this section and reference them in the appropriate sections of your quality manual. The 

laboratory must document and maintain these procedures as part of the laboratory quality system documentation.] 

Laboratory Administrative Procedures 

No. Procedure

AP No. 1 Protection of Client Confidentiality and Proprietary Rights 

AP No. 2 Impartial Service 

AP No. 3 Document Control 

AP No. 4 Ensuring Traceability (includes traceability to certified reference materials, agreed methods and/or consensus standards and 

traceability analysis) 

AP No. 5 

Handling Calibration and Test Items (Incoming inspection and review; Review of new incoming work; Receipt, retention, and 

return to include work order and work log instructions and packing and shipping instructions, avoiding deterioration, loss or

damage, security)

AP No. 6 Preventive Actions, Corrective Actions, Feedback 

AP No. 7 Internal Audits and Management Reviews (Client notification regarding adverse findings)

AP No. 8 Control of Data and Software Data Integrity (Security, access, verification of new software and protection and update of stored

data)

AP No. 9 Purchase, Storage, and Evaluation of Supplies and Services (includes inspection and verification of quality and qualification of 

subcontractors)

AP No. 10 Complaints 

AP No. 11 Laboratory Housekeeping/ Laboratory Maintenance to Support Activities and Test Results 

AP No. 12 Review and Maintenance of Control Charts (Covered in SOP 9, 17, 20) 

AP No. 13 Calibration, Verification, Maintenance, Handling, Transport, Storage, and Use of Standards 

AP No. 14 Calibration, Verification, Maintenance, Handling, Transport, Storage, Intermediate Calibration Status Checks, Updating 

Correction Status of M&TE (includes new equipment and verification of equipment outside laboratory control)

AP No. 15 Departure from Documented Policies and Procedures 

AP No. 16 Investigation of Complaints, Adverse Audit Findings or Discrepancies, and Notifying Clients when Test Results are Affected 

AP No. 17 Identifying Training Needs, Training, and Qualification of Laboratory Personnel 

AP No. 18 Control of Non-conforming Work

AP No. 19 Validation of Non-standard Test Methods to include lab designed and developed methods 

AP No. 20 Monitoring the Validity of Tests (Quality Control, Statistical Process Control) 

AP No. 21 Review of Contracts, Tenders and Work Request 

AP No. 22 Record Maintenance (Identification, Collection, Indexing, Access, Filing, Storage, Maintenance, and Disposal of Quality and 

Technical Records) 

AP No. 23 Sampling (Developing and Choosing Sampling Plans, Recording Relevant Data and Operations)

AP No. 24 Avoiding Activities that Diminish Confidence in the Competence, Impartiality, Judgement or Operational Integrity of Tests. 

AP No. 25 Use of Accrediting Body Logo 

AP No. 26 Identifying Approved Signatories 

AP No. 27 Environmental Conditions for Laboratory and Field Evaluation (acceptable limits, measuring and monitoring 

environmental conditions, making corrections due to environmental conditions that exceed the limits ) 

NISTIR 7028 65 July 2003
Appendix I 

Page 1 of 1 Assessment of Uncertainties 

(As appropriate) Uncertainties Chart for Type Evaluation Test _____________________

Range Type A 

Uncertainty 

Type B 

Uncertainty 

Combined 

Uncertainty 

Expanded Standard 

Uncertainty (k = 2) 

___________________________________________________________________________________________NISTIR 7028 66 
Appendix J 

Page 1 of 1 Control Charts List 

[NOTE: List the control charts and graphs that are maintained in the laboratory. 

The control charts numbers on this form are examples] 

No. Equipment and Standards (as appropriate) Nominal Value Comments 

ST03CC1 

ST03CC2 

ST03CC3 

NISTIR 7028 67 July 2003 
Appendix K 

Page 1 of 1 Proficiency Tests 

[NOTE: List the proficiency test and results in this section.] 

Interlaboratory / Proficiency Test Results 

Date Transfer Resu

Standard and 

Range of 

Test 

Accuracy 

Class 

Coordinating 

Organization 

Procedure 

Used 

Operator 

Passed Passed 

With 

Concerns 

 NISTIR 7028 68 
Appendix L 

Page 1 of 1 Personnel Training and Competency 

[NOTE: Record the laboratory staff training. Use a separate form for each person] 

Personnel Training and Competency 

Name of Staff

Position

Training Provider Training Dates Completed Staf

Subject/Topics From To 

Hours 

Yes No Initial 

NISTIR 7028 69 
Appendix M 

Page 1 of 3 Job Descriptions and/or Duty Statements 

[NOTE: This is a sample job description. This must be edited to fit your laboratory.] 

Job Description: Type Evaluation Laboratory Staff 

Note: Because the responsibilities of type evaluation laboratory staff vary, this job 

description is an example that only includes specific objectives and tasks. As a 

minimum, the following should be described in a job description: 

• Responsibilities for: 

− performing testing; 

− planning for tests and evaluation results; 

− reporting opinion and interpretations; 

− modification, development and validation of new methods. 

• Required expertise and experience 

• Qualifications and training programs 

• Managerial duties 

Under the direction of the State Director (or Laboratory Supervisor), the type evaluation 

laboratory staff is directed to meet the following objectives and perform the associated tasks. 

Objective - Maintain Working Standards and Test Equipment

Tasks: 1. Take charge of the working standards and assure their safekeeping. 

2. Perform periodic maintenance of the working standards including cleaning. 

3. Perform periodic maintenance on the test equipment including cleaning and 

minor adjustments. Assure that instruments such as precision balances receive 

routine preventative maintenance by qualified technicians. 

4. Arrange for calibration as needed. 

5. Ensure that the test devices are safely returned to the custody of the person or 

company that submitted them. 

______________________________________________________________________________ 

NISTIR 7028 70 July 2003 
Appendix M 

Page 2 of 3 Job Descriptions and/or Duty Statements 

Objective - Maintain the Standard and Equipment Monitoring Programs (when developed)

Tasks: 1. Select check standards and/or equipment for use in the monitoring program. 

2. Perform repeated measurements using the check standards or equipment to 

gather data for control charts as needed. 

3. Construct control charts for appropriate type evaluation tests used in the 

laboratory. Evaluate control limits. 

4. Compare new data points to these control limits to monitor the laboratory output. 

5. Document, investigate, and correct any out-of-control condition. Evaluate the 

potential impact on clients that may have been affected by the condition. Notify 

clients of significant out-of-control conditions so that they may take appropriate 

action. 

Objective - Perform Type Evaluation Examinations

Tasks: 1. Schedule the workload of the laboratory. 

2. Receive the devices submitted for test. Identify them and ensure their 

safekeeping while in the custody of the laboratory. 

3. Select and perform the appropriate tests on the device submitted following the 

procedures in the Type Evaluation Checklists. 

4. Document the tests through test worksheets and prepare the formal Certificate of 

Conformance document. Ensure that all paperwork is correct and ensure that 

copies are safely maintained for a time period defined in the laboratory's Quality 

Manual. 

5. Ensure that the devices are safely returned to the custody of the person or firm

that submitted them. 

______________________________________________________________________________ 

NISTIR 7028 71 July 2003 
Appendix M 

Page 3 of 3 Job Descriptions and/or Duty Statements 

Objective - Correspondence

Tasks: 1. Correspond with potential clients regarding the capabilities, schedules, and 

requirements of the laboratory. 

2. Answer questions regarding metrology, specifications and tolerances of 

standards and measuring equipment, and other related activities. 

3. Provide technical assistance to enforcement officials and other clients regarding 

proper use and maintenance of standards. 

______________________________________________________________________________ 

NISTIR 7028 72 July 2003 
Appendix N 

Page 1 of 5 Document Control 

No. Manuals Responsible for 

Review 

Revision Date Location 

ST03SM-01 Safety Manual 

ST03QM-01 Quality Manual 

ST03OM-01 Administrative Procedures Manual 

[NOTE: Manual numbers and format are examples only. The laboratory may have an existing format. The first 2 

digits of the manual control numbers represent the State; the second 2 digits represent the revision year; the third 2 

digits represent the type of manual, e.g., QM = Quality Manual; and the fourth 2 digits represent the revision 

number. Controlled documents that are distributed contain an additional digit representing the distribution number. 

Records of the distribution numbers are located in the laboratory files.] 

No. Administrative Forms 

Responsible for 

Review Revision Date Location

ST03AF1-01 Management Review 

ST03AF2-01 Complaints 

ST03AF3-01 Work Orders 

ST03AF4-01 Work Logs 

ST03AF5-01 

Subcontractors & Outside 

Suppliers 

ST03AF6-01 Personnel Training and 

Competency Log 

ST03AF7-01 Control Document Distribution 

List 

[NOTE: Form numbers are examples only. The laboratory may have an existing format. The first 2 digits of the 

form control numbers represent the State; the second 2 digits represent the revision year; the third 2 digits represent 

the type of form, e.g., AF = Administrative Form; the next digit identifies the specific form; and the last two digits 

______________________________________________________________________________ 

NISTIR 7028 73 July 2003 
Appendix N 

Page 2 of 5 Document Control 

represent the revision number.] 

No. Measurement-Related Forms Responsible 

for Review 

Revision Date Location 

ST03MR1-01 Environmental Conditions/Deviations 

Log 

ST03MR2-01 Calibration, Maintenance, Verification 

Log - Standards and Equipment 

ST03MR3-01 Weighing Equipment Assessment 

ST03MR4-01 Assessment of Measurement 

Uncertainties 

ST03MR5-01 Software Verification 

ST03MR6-01 Audits 

ST03MR7-01 Observation and Data Sheet 

ST03MR8-01 Type Evaluation Report 

ST03MR9-01 Test Report 

______________________________________________________________________________ 

NISTIR 7028 74 July 2003 
Appendix N 

Page 3 of 5 Document Control 

No. Administrative Procedures Responsible for 

Review 

Revision Date Location 

AP No. 1 Protection of Client Confidentiality 

and Proprietary Rights 

AP No. 2 Impartial Service 

AP No. 3 Document Control 

AP No. 4 Ensuring Traceability (includes 

traceability to certified reference 

materials, agreed methods and/or 

consensus standards and traceability 

analysis) 

AP No. 5 Handling Calibration and Test Items 

(Incoming inspection and review; 

Review of new incoming work; 

Receipt, retention, and return to 

include work order and work log 

instructions and packing and 

shipping instructions, avoiding 

deterioration, loss or damage, 

security) 

AP No. 6 Preventive Actions, Corrective 

Actions, Feedback 

AP No. 7 Internal Audits and Management 

Reviews (Client notification 

regarding adverse findings) 

AP No. 8 Control of Data and Software Data 

Integrity (Security, access, 

verification of new software and 

protection and update of stored data) 

AP No. 9 Purchase, Storage, and Evaluation of 

Supplies and Services (includes 

inspection and verification of quality 

and qualification of subcontractors) 

AP No. 10 Complaints 

AP No. 11 Laboratory Housekeeping/ 

Laboratory Maintenance to Support 

Activities and Test Results 

AP No. 12 Review and Maintenance of Control 

Charts (Covered in SOP 9, 17, 20) 

AP No. 13 Calibration, Verification, 

Maintenance, Handling, Transport, 

Storage, and Use of Standards 

______________________________________________________________________________ 

NISTIR 7028 75 July 2003 
Appendix N 

Page 4 of 5 Document Control 

AP No. 14 Calibration, Verification, 

Maintenance, Handling, Transport, 

Storage, Intermediate Calibration 

Status Checks, Updating Correction 

Status of M&TE (includes new 

equipment and verification of 

equipment outside laboratory 

control) 

AP No. 15 Departure from Documented Policies 

and Procedures 

AP No. 16 Investigation of Complaints, 

Adverse Audit Findings or 

Discrepancies, and Notifying Clients 

when Test Results are Affected 

AP No. 17 Identifying Training Needs, 

Training, and Qualification of 

Laboratory Personnel 

AP No. 18 Control of Non-conforming Work 

AP No. 19 Validation of Non-standard Test 

Methods to include lab designed and 

developed methods 

AP No. 20 Monitoring the Validity of Tests 

(Quality Control, Statistical Process 

Control) 

AP No. 21 Review of Contracts, Tenders and 

Work Request 

AP No. 22 Record Maintenance (Identification, 

Collection, Indexing, Access, Filing, 

Storage, Maintenance, and Disposal 

of Quality and Technical Records) 

AP No. 23 Sampling (Developing and Choosing 

Sampling Plans, Recording Relevant 

Data and Operations) 

AP No. 24 Avoiding Activities that Diminish 

Confidence in the Competence, 

Impartiality, Judgement or 

Operational Integrity of Tests. 

AP No. 25 Use of Accrediting Body Logo 

AP No. 26 Identifying Approved Signatories 

______________________________________________________________________________ 

NISTIR 7028 76 July 2003 
Appendix N 

Page 5 of 5 Document Control 

AP No. 27 Environmental Conditions for 

Laboratory and Field Evaluation 

(acceptable limits, measuring and 

monitoring environmental 

conditions, making corrections due 

to environmental conditions that 

exceed the limits ) 

No. References and Test Procedures 

Responsible 

for Review Revision Date Location 

______________________________________________________________________________ 

NISTIR 7028 77 July 2003 
Appendix O 

Page 1 of 11 Forms 

Forms

[Note: Include copies of the forms used in the type evaluation laboratory. The forms in this sec

___________________________________________________________________________________________NISTIR 7028 78 
Appendix O 

Page 2 of 11 Forms 

Personnel Training and Competency

Name of Staff: _________________________________________________ Position: _________________________________________________ 

Training Provider 

Subject/Topics 

Training Dates Hours Completed Staff 

From To Yes No Initial Date 

Form No. ST03AF6-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 79 
Appendix O 

Page 3 of 11 Forms 

Calibration and Maintenance Log (Standards and Equipment)

Standard or Equipment Date Condition 

on 

Receipt 

Manufacturer Model/

Serial 

Cal. Status/ 

Maintenance 

Date 

Curre

Locati

Received InService 

Form No. ST03MR2-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 80 
Appendix O 

Page 4 of 11 Forms 

Software Program Verification

Software 

Program/Version 

File Name / 

File size 

Manufacturer / 

Developer 

Verification: Data Set 

Runs 

Verification 

Date 

Verified by 

(Initials) 

Pass Fail 

Form No. ST03MR5-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 81 
Appendix O 

Page 5 of 11 Forms 

Equipment Assessment

Item Information Ac

Range Manufacturer Model Test Method Standard 

Deviation 

Yes 

Form No. ST03MR3-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 82 
Appendix O 

Page 6 of 11 Forms 

Proficiency Test Results

Date Range Accuracy 

Class 

Coordinating 

Organization 

Procedure 

Used 

Operator Result

Passed Passed 

With 

Concerns 

Fa

Form No. ST03MA3-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 83 
Appendix O 

Page 7 of 11 Forms 

Audit Log

Audit 

Description 

Date 

Conducted 

Auditor Location of 

Audit Report 

Audit Findings / Corrective Act

Form No. ST03MR6-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 84 
Appendix O 

Page 8 of 11 Forms 

Work Log

Test No. Date 

Received 

Item (s) 

Received 

Test Requested Requested 

By 

Date 

Tested 

Date 

Completed 

Re

Form No. ST03AF4-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 85 
Appendix O 

Page 9 of 11 Forms 

Complaints / Corrective Action

Subject of Complaint / 

Discrepancy 

Date Response Date Reviewed By Actions Take

Form No. ST03AF2-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 86 
Appendix O 

Page 10 of 11 Forms 

Environmental Conditions/Deviations Log 

Location Date Time Temperature 

EC 

Within "

EC 

Relative 

Humidity % 

Within " % P

Form No. ST03MR1-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 87 
Appendix O 

Page 11 of 11 Forms 

Subcontractors and Outside Suppliers Verification Log

State Metrology 

Laboratory 

Performing Test 

 Test Item(s) Date Laboratory Accredited Supplier Type of 

Supply 

Yes No Type of 

Verificati

 Perform

Form No. ST03AF5-01 Rev. Date: July 1, 2003 

___________________________________________________________________________________________NISTIR 7028 88 
 

Appendix P 

Page 1 of 10 Weighing Device Evaluation Process Flowcharts 

[Note: This appendix is an example of a weighing device type evaluation process. If you include this process 

flowchart in your quality manual it must be edited to represent your laboratory process.] 

 

[Note: (TEA) – type evaluation administrator]

DATE: Rev. 06/01/02 Doc Pg 1 OF 10 PGS

TITLE: Handling and Tracking of Test Items Pg 1 of 2

Start

Review of control number & device

information from TEA

Scheduling

Was the device received

within 11 weeks (77 days) of the

assignment date?

Was the laboratory

contacted by mfg within 30 days

of the assignment date to set up

test date?

Field evaluation

Yes

Will the device be evaluated

in the laboratory? No

1

No

Yes

No

1. Information is reviewed by the TEA Program Manager.

2. Summary sheet is started.

1. Withdraw the assignment .

2. Send written notification of withdrawal to the

 contact person and to TEA.

2

Yes

Device receipt process

When contacted by the manufacturer, the type evaluation

representative will:

1. Review the application with the device contact person.

2. Select and review the test procedures and get agreement 

 from the device contact person.

3. Inform the contact person of the equipment and any special

 equipment required to complete the evaluation.

Weighing Devices to include: automatic weighing systems, axle-load, beltconveyor, counter,

bulkweigher, crane, floor, grain test, hanging, hopper, indicating element, jeweler, livestock, on-board

weighing system, POS, postal, prepackaging, prescription, shipping, vehicle, weight classifier,

wheel-load weigher

go to Pg 7 of 10

go to Pg 2 of 10

Was device received

before TEA assigned control

number?

No

Yes

 1. Notify mfg of the test process.

 2. Notify TEA.

 3. Control number must be issued before testing begins.

 1. Withdraw the assignment .

 2. Send written notification of withdrawal tothe contact person 

 and to TEA.

_____________________________________________________________________________________________

NISTIR 7028 89 July 2003 
 

Appendix P 

Page 2 of 10 Weighing Device Evaluation Process Flowcharts 

The device is evaluated

W as the device package(s)

received by Lab staff?

R eceipt by Lab staff

Receipt by Office Staff

3

W ork schedule

(enter in w ork log and

start sum m ary sheet)

No

Yes

D ATE: Rev. 06/01/02 D oc Pg 2 OF 10 PGS

TITLE: H an d lin g an d T rackin g o f T est Item s Pg 2 of 2

D evice is returned

Procedure for receiving test item

shipm ents:

1. D ate and initial the package(s).

2. Place package(s) in storage room .

3. Notify the lab Program Manager.

2

1. Date and initial the package(s).

2. Inspect the package(s) for dam age and content.

3. Place the package(s) in storage room .

1. R ecord date of receipt and other info on work

 log.

2. Notify TEA of the date of receipt.

3. Schedule: w ork is conducted in the order in

 w hich the devices are received.

4. Docum ent all w ork on the sum m ary sheet.

1.Devices are packaged and shipped by the

 lab staff.

2.Devices are returned after final edit of the C C

 drafts by TEA.

3.Unless other m eans are requested by the

 m anufacturer, devices are shipped through

 UPS, or FED EX.

go to Pg 3 of 10

7 go to Pg 5 of 10

_____________________________________________________________________________________________

NISTIR 7028 90 July 2003 
 

Appendix P 

Page 3 of 10 Weighing Device Evaluation Process Flowcharts 

TITLE: Conducting Laboratory Type Evaluations Pg 1 of 2

Initialization of evaluation

Initial checklist review

Influence factors testing

1. Set-up device in environmental chamber.

2. Accuracy test over operating temperature range

3. If fails, contact manufacturer

4. Return device if appropriate or retest @ diff temp range

Ideal time: _________

Factors affecting time: Time needed for device to reach the

set temperature. repeating borderline tests

3

DATE: Rev. 06/01/02 Doc Pg 3 OF 10 PGS

1. Record the date the evaluation is started and notify TEA of the start

date.

2. Review installation and operation manuals.

3. Device set-up and accuracy test

4. Device recalibration as necessary

5. HB-44 visual review

6. If areas of noncompliance will affect other tests, notify the manufacturer

of the areas of noncompliance and that testing has been discontinued.

Ideal time: _________

Factors affecting time: complexity of setup and

calibration. Size of manuals to review

Any failures?

No

1. Complete checklist review

2. Document any areas of noncompliance.

3. If areas of noncompliance will affect other tests, notify the

 manufacturer of the areas of noncompliance and that testing

 has been discontinued.

Ideal time: _________

Factors affecting time: repeating borderline tests

Any failures?

No

Any

failures?

No

5

Yes

Yes

Yes

4

4

4

Go to Pg 4 of 10

Go to Pg 6 of 10

Weighing Devices to include: automatic weighing systems, axle-load, beltconveyor, counter, bulkweigher, crane, floor, grain

test, hanging, hopper, indicating element, jeweler, livestock, on-board weighing system, POS, postal, prepackaging,

prescription, shipping, vehicle, weight classifier, wheel-load weigher

Go to Pg 6 of 10

Go to Pg 6 of 10

_____________________________________________________________________________________________

NISTIR 7028 91 July 2003 
 

Appendix P 

Page 4 of 10 Weighing Device Evaluation Process Flowcharts 

Permanence testing

Voltage testing

Final checklist review

1. Conduct accuracy test every 25,000 cycles

 (total: 100,000 cycles).

2. If fails, notify manufacturer.

3. Recalibrate & repeat testing from beginning at mfg.

 request.

4. If device returned and resubmitted, review mfg.

 corrections.

5. Retest for permanence and repeat influence factors

 testing as necessary.

Ideal time:________

Factors affecting time: Time required for stable

 reading (updating), repeating influence factor test if necessary

1. Conduct accuracy test at min, max and nominal volts.

2. If fails, notify manufacturer.

3. If device returned and resubmitted, review mfg.

 corrections.

4. Repeat voltage testing. Repeat influence factors and/or

 permanence testing as necessary.

Ideal time: ________

Factors affecting time: repeating borderline test, influence

and/or permanence tests

6

Any

failures?

No

Any failures?

Any failures?

No

No

5

Yes 4

If device does not meet all applicable requirements:

1. Send the manufacturer written documentation of

 the areas of noncompliance.

2. Reference the section of the requirement and note the

 reason the section has not been met.

Ideal Time: _________

Factors affecting time: Number of issues to

 address, complexity of the issues, complexity of device

Yes 4

Yes 4 Go to Pg

6 of 10

Go to Pg 5 of 10

10 from Pg 9

and 10 of 10

TITLE: Conducting Laboratory Type Evaluations Pg 2 of 2

DATE: Rev. 06/01/02 Doc Pg 4 OF 10 PGS

Go to Pg

6 of 10

Go to Pg

6 of 10

_____________________________________________________________________________________________

NISTIR 7028 92 July 2003 
 

Appendix P 

Page 5 of 10 Weighing Device Evaluation Process Flowcharts 

TITLE: D rafting The C ertificate of C on fo rm an ce Pg 1 of 1

W rite draft

Certificate of Conform ance

Send draft CC to m fg for review

Send CC to TEA

Contact TEA

1. Use CC m acro to draft the CC

Ideal tim e:_________

Factors affecting tim e: Laboratory's workload,

 additional program and section duties,

 com plexity of the CC(num ber of devices to be

 included, operation instructions) 

DATE: Rev. 06/01/02 Doc Pg 5 OF 10 PGS

6

7

1. Provide TEA with date that evaluation was com pleted.

2. Request an effective date and CC num ber within one

 week of evaluation com pletion.

Ideal tim e:________

Factors affecting tim e: Laboratory's workload,

additional program and section duties

1. Draft CC is faxed to m fg.

2. Mfg returns review.

3. Make any necessary changes to CC

4. Repeat steps 1 - 3 as appropriate

5. Record total tim e for m fg review of draft CC (for type evaluation

adm inistrator records, as appropriate).

6. Prepare the final CC.

Review tim e lim it for m fg :_________

Ideal tim e:_________

Factors affecting tim e: Laboratory's workload,

additional program and section duties, delayed

resubm ittal by m anufacturer

1. Final CC is sent to TEA via e-m ail attachm ent and verified

 with a phone call.

Ideal tim e: ________

Factors affecting tim e: Laboratory's workload,

additional program and section duties

go to Pg 2 of 10

W eighing Devices to include: automatic weighing systems, axle-load, beltconveyor, counter, bulkweigher, crane, floor, grain test, hanging, hopper, indicating

element, jeweler, livestock, on-board weighing system, POS, postal, prepackaging, prescription, shipping, vehicle, weight classifier, wheel-load weigher

Does the final data

need a review by TEA, Canada or other

type evaluation laboratory?

Yes

1. Send data to TEA, Canada or other type evaluation laboratory.

2. Data reviewed and appropriate com m ents sent back to laboratory.

3. Final review by laboratory.

No

_____________________________________________________________________________________________

NISTIR 7028 93 July 2003 
 

Appendix P 

Page 6 of 10 Weighing Device Evaluation Process Flowcharts 

4

Failure

has the device failed 

3 times or has total time

exceeded 

policy?

No

ContactTEA

Yes

1. review all other associated tests to identify any other non compliances

2. notify manufacturer

DATE: Rev. 06/01/02 Doc 6 Pg OF 10 PGS

TITLE: Type Evaluation Failure Process Pg 1 of 1

back to the 

type 

evaluation 

process

if lab type evaluations

rtn to connector

back to the 

type 

evaluation 

process

if field type evaluations

rtn to connector

1. Failure:

All unresolved deficiencies found until the point that no other testing can be conducted. All deficiencies found during permanence testing is

considered a failure. Written correspondence is sent to the manufacturer after each failure to include all deficiencies found and NIST is notified. (see 

Publication 14, Administrative Procedures, Section Q - Report of Deficiencies).

2. NON-failure: In laboratory or initial field evaluation

Deficiencies corrected while the inspector is present and testing, and there is minimal time delay to the testing. The inspector should document the 

deficiencies but this is not considered a failure and will not require the issuance of an updated control number. There is no written correcspondance 

notifying the manufacturer of noncompliances since the corrections were made while the inspector was present. 

Continue 

testing

(device must

be submitted 

in 30 days)

TEA

Are reasons

on acceptable failures

list?

No

return device if

necessary or

manufacturer

repairs device at the 

laboratory or at the 

field site.

No

TEA

determines if

acceptable based on 

laboratory

recommendation

Are reasons

determined 

acceptable?

Yes

Expand list of

acceptable failures

Provide updated list to 

laboratories

TEA

control number

updated

notify TEA and 

Manufacturer of 

failure(s), TEA issues

updated control

number (e.g. XXXX.1, 

XXXX.2)

LAB

notify manufacturer that

additional documented 

evidence (report, data)

and/or testing is

required within 90 days

No

TEA

File

closed

TEA and Lab

Review test Data

TEA and LAB

is test data acceptable?

No

Yes

The entire Excessive Failure Process

cannot exceed 90 days (May go through this portion of the process more than once as

long as the total time does not exceed 90 days)

device 

corrected in

90 days and rtned 

as lab scheduling 

permits

File

closed

No

TEA

Has device ever

entered the excessive 

failure process

Yes

TEA

close file

Yes

Manufacturer

evidence and/or

test data 

submitted

Has the 

manufacturer exceeded the 

90 days process

No

Yes

NOTE: device 

goes to the end of 

the queue

Yes

Allow for lab

scheduling 

problems

Yes

_____________________________________________________________________________________________

NISTIR 7028 94 July 2003 
 

Appendix P 

Page 7 of 10 Weighing Device Evaluation Process Flowcharts 

TITLE: Conducting Initial Field Performance Type Evaluations Pg 1 of 2

DATE: Rev. 06/01/02 Doc Pg 7 OF 10 PGS

1

Field evaluation

W as the evaluation

scheduled within

11 weeks (77 days) of the

assignment date?

Make travel

arrangements

Initialization of the field

evaluation / preliminary

test

Travel to test site

Did manufacturer

cancel and unable to

reschedule within the initial 11

weeks (77 days)?

Yes

1. W ithdraw the assignment.

2. Send written notification of withdrawal to the manufacturer and to the TEA.

W hen contacted by the manufacturer with an evaluation date the tlab staff:

1.Checks assignment calendar for availability.

2.Requests authorization number for travel.

3. Makes travel arrangement s.

Ideal Time:________

Factors affecting time: Scheduling delays by

manufacturer, the schedule of the evaluator.

Ideal Time:

Factors affecting time: Distance from Lab to test site

1. Review test site.

2. Review setup parameters of the system.

3. Preliminary tests: review the checklist.

4. If any failures:

 a. If the areas of noncompliance are corrected, repeat the

 preliminary testing.

 b. If the areas of noncompliance cannot be corrected, discontinue

 the evaluation. Notify the manufacturer of the areas of concompliance.

Ideal Time:________

Factors affecting time: Complexity of the system

1. Review device diagram.

2. Verifiy evaluation of components (i.e., load cell certificate review).

3. Review installation and operation manuals.

Ideal Time:_______

Factors affecting time: Complexity of schematics,

 questionable components, lengthy manuals

1. W ithdraw the assignment.

2. Send written notification of withdrawal to the manufacturer and to theTEA.

No

8

No

Yes

Go to Pg 8 of 10

Scales and W eighing Devices to include: automatic weighing systems, axle-load, beltconveyor, counter, bulkweigher,

crane, floor, grain test, hanging, hopper, indicating element, jeweler, livestock, on-board weighing system, POS, postal,

prepackaging, prescription, shipping, vehicle, weight classifier, wheel-load weigher

_____________________________________________________________________________________________

NISTIR 7028 95 July 2003 
 

Appendix P 

Page 8 of 10 Weighing Device Evaluation Process Flowcharts 

D ATE: R ev . 06/01/02 Do 8 c Pg O F 10 P G S

A ny

failures?

Accuracy testing

Any failures?

R eview test results

T ravel from tes t s ite to

lab

Y es

N o

N o

4

8

1.R ev iew tes t procedure w ith equipm ent operator.

2. C onduc t tes t

3. If any failures :

a. If the areas of noncom pliance are correc ted, repeat the 

 prelim inary and ac curacy tests.

b. If the areas of noncom pliance cannot be correc ted, dis continue 

 the evaluation. N otify the m anufac turer of the areas of

 noncom pliance.

Ideal Tim e: _______

Fac tors Affec ting T im e: C apac ity of device, tes t

Y es 4 equipm ent available, num ber of test to be conduc ted

1.Seal all adjustable com ponents .

2. R ev iew all data.

3. R ev iew test results and perm anence tes t use requirem ents

 w ith the m anufac turer.

4. Schedule perm anence tes t date.

Ideal Tim e:_______

Fac tors Affec ting tim e: Type and am ount of data to

 rev iew

Ideal Tim e:_______

F actors affec ting tim e: D is tance from lab to tes t s ite 

9 go to P g 9 of 10

T ITLE : C ond u ctin g In itial Field Perfo rm an ce T yp e Ev alu ations P g 2 o f 2

go to P g 6 of 10

_____________________________________________________________________________________________

NISTIR 7028 96 July 2003 
 

Appendix P 

Page 9 of 10 Weighing Device Evaluation Process Flowcharts 

TITLE: C onducting Subsequent Field Perm anence Type Evaluations Pg 1 of 2

W as the evaluation scheduled in

order to conduct test within 20-30 days

after the initial test? If not, no

more than 11 weeks (77 days)

after initial test?

Make travel

arrangements

Travel to test site

DATE: Rev. 06/01/02 Doc Pg 9 OF 10 PGS

Yes

9

1. W ithdraw the assignment .

2. Send written notification of withdrawal to the contact person and to TEA.

Did manufacturer

cancel and unable to

reschedule within the initial

11 weeks (77 days)

Yes

1. W ithdraw the assignment .

2. Send written notification of withdrawal to the contact person and to TEA.

No

W hen contacted by the manufacturer with an evaluation date the type

evaluation representative will:

1.Check assignment calendar for availability.

2.Request authorization number for travel.

3. After receipt of authorization number, make travel

 arrangement through authorized travel agent.

Ideal Time: ______

Factors affecting time: Scheduling delays by

manufacturer. The schedule of the evaluator.

Ideal Time:_______

Factors affecting time: Distance from Lab to test site

Initialization of

permanence testing/

preliminary test

1. Review test site and visual evaluation of device.

2. Review setup parameters of the system.

3. Preliminary tests per checklist

4. If any failures, discontinue the evaluation. Notify the manufacturer of the 

 areas of noncompliance.

Ideal Time:_______

Factors affecting time: Complexity of the system

11

Is subsequent field

permanence testing

required?

No 10 Go to Pg 4 of 10

No

Yes

Go to Pg 10 of 10

W eighing Devices to include: automatic weighing systems, axle-load, beltconveyor, counter, bulkweigher, crane, floor, grain

test, hanging, hopper, indicating element, jeweler, livestock, on-board weighing system, POS, postal, prepackaging,

prescription, shipping, vehicle, weight classifier, wheel-load weigher

_____________________________________________________________________________________________

NISTIR 7028 97 July 2003 
 

Appendix P 

Page 10 of 10 Weighing Device Evaluation Process Flowcharts 

DATE: Rev. 06/01/02 Doc Pg 10 OF 10 PGS

Any failures?

Accuracy testing

Any failures?

Review test results

Travel from test site to

lab

Yes

No

No

4

11

1.Review test procedure with equipment operator.

2. Conduct test as prescribed in Publication 14.

3. If any failures discontinue the evaluation. Notify the manufacturer of the

 areas of noncompliance.

Ideal Time:________

Factors Affecting Time: Capacity of device, test

equipment available, number of test to be conducted

Yes 4

1. Review all data.

2. Review test results and permanence test use requirements with the

 manufacturer.

Ideal Time:_______

Factors Affecting time: Type and amount of data to

review

Ideal Time:_______

Factors affecting time: Distance from lab to test site

10 Go to Pg 4 of 10

go to Pg 6 of 10

TITLE: C onducting Subsequent Field Perm anence Type Evaluations Pg 2 of 2

_____________________________________________________________________________________________

NISTIR 7028 98 July 2003 
Appendix Q 

Page 1 of 1 Laboratory Documentation Outline 

Quality 

Manual

Test Procedures

Laboratory

Administrative Procedures

Work Instructions

Records, Forms, Reports

Equipment Instruction Manuals

Type of Testing Documentation Weighing Measuring Grain Moisture / NIR Linear 

Quality Manual All applies All applies All applies All applies 

NCWM Publication 14

“Administrative 

Procedures, Technical 

Policy, Checklists and 

Test Procedures”

Adm. procedures, 

and § 2, Chap 1, 2,

3, 4, 5, and 8. 

Adm. procedures, 

and § 2, Chap 9 and 

10. 

Adm. procedures, and

§ 2, Chap 8 and 9. 

Adm.

procedures 

and § 2, 

Chap. 11. 

Laboratory

Administrative 

Procedures 

All (Appendix H) All (Appendix H) All (Appendix H) All

(Appendix H)

Work Instructions List List List List 

Records, Forms and 

Reports 

List List List List 

Equipment Instruction 

Manuals

List List List List 

[NOTE: List the procedures, instructions, records, and forms for the type of testing performed in the laboratory] 

_____________________________________________________________________________________________

NISTIR 7028 99 July 2003 
Appendix R 

Page 1 of 1 Traceability Flowchart 

[NOTE: Edit this traceability chart to represent your laboratory chain of traceability.] 

NIST

State M etrology Laboratory

M ass Standards

Type Evaluation Laboratory

M ass W orking Standards

State M etrology Laboratory

Volum e Standards

NIST

Type Evaluation Laboratory

Volum e W orking Standards

Scale Type Evaluation

Tests

M easuring Device Type

Evaluation Tests

 

End of Document 

_____________________________________________________________________________________________

NISTIR 7028 100 July 2003